Freedom of Information request on how many adverse reports have been filed for TMJ implants (jaw), specifically the Christensen implants and information around how these procedures are regulated ( FOI 21/1209)
Published 26 May 2022
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FOI 21/1209
30th November 2021
Dear,
Thank you for your email dated 2nd November 2021, where you asked the MHRA to confirm how many adverse reports have been filed for TMJ implants (jaw), specifically the Christensen implants and information around how these procedures are regulated.
We are able to provide you with some of the information requested, see below.
Since 2018, the MHRA has received 36 adverse reports from manufacturers under the device description ‘Temporomandibular Implants’. The MHRA cannot share information on the Christensen implants because it relates to an adverse incident investigation or that is specific to named manufacturers. This includes makes and models, which would identify the manufacturer.
The information you have asked for is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA)
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested:
- constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002, and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
- relates to the affairs of Nexus CMF (previously Christensen, TMJ Implants Inc.; Salt Lake City, UT, USA), a business which continues to exist.
If you haven’t already done so, we would appreciate it if you could complete a yellow card report to provide us with further details on the incident and the affected device.
Yellow card reports are shared with the manufacturer. It is the responsibility of the manufacturer to conduct an appropriate investigation into the cause of any problems with their devices. The role of the MHRA is to ensure the manufacturer follows their stated quality management processes and that these continue to be fit for purpose for the devices to remain acceptably safe. We are continuing to undertake routine trending and surveillance activities on all devices, including Temporomandibular Implants and Yellow card reports feed into this review.
If the manufacturer or MHRA identifies a safety issue with this medical device, this will be communicated to the manufacturer’s customers and the health service through one or more of these communication routes.
If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for an internal review. It will be carried out by a senior member of the Agency who was not involved with the original decision. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review.
The Information Commissioner can be contacted online: https://ico.org.uk/make-a-complaint/official-information-concerns-report/official-information-concern/
or by post: Information Commissioner’s Office, Wycliffe House, Water Lane, Wilmslow, Cheshire SK9 5AF
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU
Telephone 0203 080 6000