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> Southwest Region
> Denver District Office
> Bldg. 20-Denver Federal Center
> P.O. Box 25087
> 6th Avenue & Kipling Street
> Denver, Colorado 80225-0087
> Telephone: 303-236-3000
> FAX: 303-236-3100
>
> February 24. 2004
>
> WARNING LETTER
>
> CERTIFIED MAIL
> RETURN RECEIPT REQUESTED
>
> Dr. Robert W. Christensen
> President/CEO
> TMJ Implants, Inc.
> 17301 W. Colfax Ave.
> Suite 135
> Golden, Colorado 80401
>
> Ref. # - DEN-04-05
>
> Dear Dr. Christensen:
>
> An inspection of your firm located at 17301 W. Colfax Ave., Golden, Colorado
> was conducted between July 29-August 11, 2003, by Investigators Nicholas R.
> Nance and Patricia A. Cortez. This inspection determined that your firm
> manufactures fossa eminence prostheses, condyle prostheses and related items
> for temporomandibular joint (TMJ) implantation. These are devices as defined
> by section 201 (h) of the Federal Food, Drug and Cosmetic Act (the Act).
>
> The above-stated inspection revealed that your devices are misbranded within
> the meaning of section 502(t)(2) of the Act in that your firm failed or
> refused to furnish information to the Food and Drug Administration (FDA) as
> required by or under section 519 of the Act and the Medical Device Reporting
> (MDR) Regulation, Title 21, Code of Federal Regulations, Part 803 (21 CFR
> Part 803). Specifically, you failed to submit MDR reports to FDA after
> receiving information which reasonably suggested that one of your
> commercially distributed devices may have caused or contributed to a death or
> serious injury. Section 519(a)(2)(C) specifically defines the term ?serious
> injury? to include an injury that necessitates medical or surgical
> intervention to preclude permanent impairment of a body function or permanent
> damage to a body structure. MDR reports are required for the following event
> numbers, assigned by your complaint system, along with any other reports that
> you have received which reasonably suggest that one of your distributed
> devices may have caused or contributed to a death or serious injury or has
> malfunctioned and such device or similar device marketed by your firm would
> be likely to cause or contribute to a death or serious injury, if the
> malfunction were to recur.
>
> [redacted] Information in the complaint indicated that the left fossa and
> condyle prostheses were explanted. During surgery, it was noted that two
> screws were broken. Complaint follow-up notes that there was an off-label use
> in that the condylar devices were secured contrary to TMJ Implants
> ?Instructions for Use?. Your firm noted that there were [redacted] screws
> securing the condyle, and that the ?Instructions for Use? recommend the use
> of [redacted] screws per condyle. Your firm also noted that the screws were
> only placed at the bottom of the condyle, and there were no screws securing
> the top half of the condyle. Your firm indicates that the off-label use would
> have caused a sufficient amount of stress to break the screws. Your firm
> concluded that the failure of the screws was caused by the off-label use and
> not a deficiency of the device. This event is reportable as a serious injury
> MDR even though it was apparently caused by user error.
>
> [redacted] This complaint relates to a voluntary MedWatch report indicating
> there was medical intervention to preclude permanent impairment of a body
> function or body structure. After implantation of the device, the patient
> experienced significant swelling, increased pain and eventually decreased
> mobility. The patient was treated with [redacted] different types of
> antibiotics. Blood work showed no sign of infection, but when the patient was
> taken off the antibiotics, swelling and pain worsened. [redacted] months
> after surgery, it was still not possible to document an infection. Although
> your firm may have decided not to report this event as an MDR, the complaint
> file did not support a conclusion that a device-related adverse event did not
> occur. This event is reportable as a serious injury MDR.
>
> [redacted] Three MedWatch reports were combined into one complaint,
> [redacted] by your firm. The event description for MW1026641 states that the
> patient received a Christensen fossa and condyle which had to be explanted
> due to bone growth and the jaw fusing shut. The event description for
> MW1026649 states that the patient received a Christensen fossa bilaterally.
> One year later the patient began having grand mal seizures for the first
> time. The patient now has persistent migraine and facial swelling which has
> closed off the ear canal and causes black eyes. The screws from the fossa
> have loosened and have penetrated through to the zygomatic arch. The event
> description for MW1026650 states that the patient received [redacted]
> Christensen fossas. The patient has been experiencing headaches. The patient
> has also been experiencing pain when chewing and constant pain in the jaw
> joint area. Complaint [redacted] was submitted to your firm as MW1026765. The
> event description states that the patient received a total TMJ joint on the
> [redacted] side. The patient?s jaw now deviates to the [redacted] and there
> is a decrease in the mouth opening. The patient is experiencing pain,
> frequent sinus infections, and migraine headaches. In the complaint file,
> your firm indicated that it received insufficient information to investigate
> these complaints. Your firm indicated that it did not receive information
> concerning the date of surgery; the device model number or lot number; or the
> name of the patient for these events. Your firm concluded that, because there
> is no indication from a health professional for complaints that a device
> failure occurred, the events are not MDR reportable. However, the information
> in the event descriptions reasonably suggests that your firm?s device may
> have caused or contributed to the reported events. These MedWatch reports
> should have been submitted as serious injury MDR?s.
>
> [redacted] Information in the complaint indicates that there was metal
> fatigue fracture of the [redacted] glenoid fossa prosthesis. An MRI
> examination revealed recurrence of ankylosis and heterotopic bone formation
> in the [redacted] TM joint arising off the mandibular condyie and
> encompassing the glenoid fossa prosthesis. The patient had been involved in
> [redacted]. This event is reportable as a serious injury MDR.
>
> [redacted] The complaint states that a postoperative diagnosis was reported
> as bilateral temporomandibular joint alloplastic prosthesis failure. The
> [redacted] condylar prosthesis screws were all loose and out of the bone. The
> [redacted] condylar prosthesis was malpositioned. Both condylar prostheses
> were eroding into the temporal bone. There is no information on the complaint
> form indicating an MDR reportability decision nor is the MDR Evaluation
> Checklist form completed even though the file was closed 7/17/03. This event
> is reportable as a serious injury MDR.
>
> [redacted] Information in the operative report related to explantation of the
> device indicates that the patient had degenerative disease including
> inflammation which contributed to the wear of the prosthesis, as well as bone
> screw loosening in the [redacted] condyle component which may have
> contributed to the patient?s pain. This event is reportable as a serious
> injury MDR.
>
> [redacted] The surgeon indicated that there was an explant of the prosthesis
> due to bilateral TMJ pain. Your firm did not obtain more information from the
> physician regarding the surgery. Unless your firm obtains additional
> information supporting the conclusion that a device related adverse event did
> not occur, this event is reportable as a serious injury MDR.
>
> [redacted] The information in the complaint indicates that the [redacted]
> fossa-eminence prosthesis was removed because the condyle was deformed and
> arthritic clinically. The patient?s history indicates continuing pain,
> swelling and restricted opening since fossa arthroplasty with the Christensen
> device. The complaint also states ?This is continuation of disease.? This
> record does not support a conclusion that a device related adverse event did
> not occur, and this event is reportable as a serious injury MDR.
>
> [redacted] Information in the complaint indicates that the patient had a
> history of [redacted] and the [redacted] prosthesis was explanted due to
> pain, infection, inflammation and limited opening. The [redacted] side
> histologically showed localized foreign body reaction in soft overlying
> tissues with recurrent formation of salivary fistula. Several mobile screws
> in the [redacted] fossa-eminence prosthesis area were noted at explant. This
> event is reportable as a serious injury MDR.
>
> [redacted] Information in the complaint indicates that the [redacted] side
> prosthesis was removed due to infection. Information from the physician
> indicates that the [redacted] prosthesis perforated from the posterior of the
> fossa-eminence, through the bone of the external auditory canal, and into the
> external auditory canal cartilage above the tympanic membrane. This event is
> reportable as a serious injury MDR.
>
> [redacted] Information in the complaint indicates that bilateral total
> prostheses were removed in order to clear up an infection and perforation
> between the external auditory canal and joint space. At operation, the screws
> in the condylar portion of the [redacted] hand. side were all loose except
> for the inferior two screws, which were marginally tight. One of the screws
> was completely lifted out of its hole in the condylar portion of the
> prosthesis. The tissue showed moderate acute and chronic inflammation and
> fibrinoid necrosis. This event is reportable as a serious injury MDR.
>
> [redacted] Complaint information indicates prosthesis was removed due to
> loose hardware and infection. The physician noted that longer screws were
> needed for the explanted device. This event is reportable as a serious injury
> MDR.
>
> [redacted] Complaint information indicates the reason for explant was pain,
> limited opening, swelling and malocclusion, At operation, the, [redacted]
> fossa was found to be eroded and the cranial was loose. The [redacted]
> condyle was loosening and there was dislocation of the fossa implant. The
> [redacted] condyle was loose. The screws were also loose. Tissue from the
> mandibular joints was chronically inflamed with fibrosis. The surgeon noted
> that with abnormal anatomy the implanted devices became unstable. This event
> is reportable as a serious injury MDR.
>
> [redacted] According to the complaint information, surgery was performed to
> replace fossa screws due to improper screw fit. There is no information in
> the complaint regarding reasons for the improper screw fit including the
> possibility of user error. This event is reportable as a serious injury MDR.
>
> [redacted] The complaint information indicates that a [redacted]
> fossa-eminence prosthesis was explanted. The reason for the explant surgery
> was a failed fossa and adhesions. It was noted during the operation that
> there was marked resorption to [redacted] condylar head. The posterior and
> third screws were found to be loose and somewhat backed out. There also
> appeared to be heterotropic bone along these areas as well. The postoperative
> diagnosis was stated to be progressive degenerative joint disease of the left
> TMJ. This event is reportable as a serious injury MDR.
>
> [redacted] Four MedWatch complaints were combined into one complaint by your
> firm. The event description for MW1027888 states that patient is currently
> experiencing foreign body reaction to joints. The patient?s symptoms include
> ear pain, ear ringing, dizziness, vertigo, headaches, swelling and tenderness
> around joint area and neck and shoulder pain. The patient also stated that
> the implant screws may be loose. The event description for MW1027889 states
> that the patient is having problems with migraine headaches and jaw pain and
> there is limited jaw opening. The patient states that pain has been worse
> since the device was implanted. The event description for MW1027890 states
> that implants were removed after [redacted] due to ear pain and fibrosis and
> osteophytes were discovered during the explant surgery. The patient was told
> by the surgeon that the implants didn?t take. The condyles were reconstructed
> because of huge bone spurs and masses of fibrosis. The patient continues to
> experience headaches and ear pain and ringing. The patient is taking
> medication to control the pain. The event description for MW1027891 states
> there was a fossa placement and that the joint is sticking and the patient is
> experiencing pain and migraine headaches. The patient states that the doctors
> had to cut the bone away and then did a one time radiation treatment to help
> prevent bone from growing back. Even though the devices in these events were
> not returned to the manufacturer and the events were not submitted by a
> health professional, the information in these four MedWatch reports
> reasonably suggests that your firm?s devices may have contributed to the
> reported events. These MedWatch reports should have been submitted as four
> individual serious injury MDRs.
>
> [redacted] The complaint was submitted to your firm as MW1028047. The
> information in the event description indicated that Christensen metal on
> metal total TMJ?s were placed bilaterally. The patient developed severe,
> disabling headaches, muscle pain in and around the implant, and serious
> tenderness in and around the implant area. Dizziness, nausea and neck and
> shoulder pain accompany the problem. Chewing, speaking, or any bump on the
> chin exacerbates the problems. The patient is on anti-inflammatory and
> medications for chronic pain which help. The patient believes that the
> situation appears to be attributable to foreign body reaction or other
> problems with the implant. The reporter did not request anonymity. Your
> complaint file states that there is no information from a health professional
> to indicate a device failure or that the device caused or contributed to the
> event. The information in the event description is insufficient to support a
> conclusion that a device related adverse event did not occur. This event is
> reportable as a serious injury MDR.
>
> [redacted] Your firm?s devices were explanted due to pain and swelling. On
> operation it was found that the acrylic condyle appeared to be worn and
> flattened and granulation tissue surrounded the condyle. The surgeon felt
> that a couple of large submandibular nodes were concurrent with an
> inflammatory reaction to the wear of the device. The explanting surgeon
> believed the device caused or contributed to the need for the explant. This
> event is reportable as a serious injury MDR.
>
> [redacted] The limited information in the complaint indicates that the
> patient has ankylosis and cannot open more than 12mm. The [redacted]
> prostheses were removed and replaced. The information in the event
> description is insufficient to support a conclusion that a device related
> adverse event did not occur. This event is reportable as a serious injury
> MDR.
>
> [redacted] The limited information in the complaint indicates that the
> physician treated [redacted], post operation infections in [redacted]
> different patients. The information in the event description is insufficient
> to support a conclusion that a device related adverse event did not occur.
> This complaint should have been submitted as two serious injury MDRs.
>
> [redacted] According to the information in the event text, the surgeon
> implanted the Fossa-Eminence sizers instead of the actual devices. Your firm
> advised the physician to remove the sizers which was done the next day and
> the correct prostheses were implanted. This event is the result of user
> error. This event is reportable as a serious injury MDR.
>
> Written MDR reports for the above listed incidents should be submitted within
> 15 working days of receipt of this letter. If these reports cannot be
> submitted within that time period, you should provide this office with a
> response which indicates when the reports will be submitted. The MDR reports
> should reference this Warning Letter and be directed to:
>
> Ms. Victoria A. Schmid
> Division of Surveillance Systems (HFZ-533)
> Office of Surveillance and Biometrics
> Food and Drug Administration
> 1350 Piccard Drive
> Rockville, Maryland 20850
>
> This letter is not intended to be an all-inclusive list of deficiencies at
> your facility. It is your responsibility to assure adherence with each
> requirement of the regulations, as well as other requirements of the Act.
>
> You should take prompt action to correct these deviations. Failure to
> promptly correct these deviations may result in regulatory action without
> further notice. These actions include, but are not limited to seizure,
> injunction, and/or civil penalties.
>
> Federal agencies are advised of the issuance of all warning letters regarding
> medical devices so that they may take this information into account when
> considering the award of contracts.
>
> We could not properly evaluate one other adverse event in which an injury may
> have resulted from a device malfunction, because there was insufficient
> information to make a determination of MDR reportability. In event
> [redacted], the only information found in the complaint was that [redacted]
> fossa eminences and [redacted] condyles were explanted, and that they were
> replaced with other prostheses on [redacted]. There is no information
> regarding the reason for the explants. The device evaluation by your firm
> notes wear on all of the returned prostheses. There is insufficient
> information in the complaint to support a conclusion that a device-related
> adverse event did not occur.
>
> FDA has communicated similar concerns regarding your firm?s failure to submit
> MDR?s in the letters of October 23, 2002, and March 13 and April 28, 2003. It
> appears that you have had difficulty understanding how to implement the
> requirements in the MDR regulation and have therefore failed to submit MDR?s.
> In your August 25, 2003, response concerning our investigator?s observation
> #2 regarding MDR reporting on the form FDA 483, your firm agreed to reassess
> your MDR reporting. However, we note that you have not yet filed MDR?s for
> these events.
>
> Your August 25, 2003, response concerning the observations on the
> Inspectional Observations, form FDA 483, regarding the Quality System
> regulation deviations appears to be adequate.
>
> Please notify this office in writing within fifteen (15) working days of
> receipt of this letter, of the specific steps you have taken to correct the
> noted violations, including an explanation of each step being taken to
> prevent the recurrence of similar violations. If corrective action cannot be
> completed within 15 working days, state the reason for the delay and the time
> frame within which the correction will be completed.
>
> Your reply should be sent to the Food and Drug Administration, Denver
> District Office, Attention: H. Tom Warwick, Compliance Officer. Please
> provide Mr. Warwick with a copy of each MDR report sent to Ms. Victoria
> Schmid.
>
> Sincerely,
>
> /s/
>
> Susan J. Miller for
> B. Belinda Collins
> District Director
>
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