TMJ SYSTEM 99-6587Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841036057473), received between Jun 12, 2019 and Aug 5, 2020 — classified as 5 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT THEY ARE EXPERIENCING VARIOUS ISSUES FOLLOWING IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE LEFT SIDE APPROXIMATELY ELEVEN (11) YEARS AGO. THE IMPLANTING SURGEON REPORTS THAT THERE WERE NO ISSUES WITH THE IMPLANTS DURING FOLLOW-UP APPOINTMENTS. THE PATIENT REPORTS A GASH ON THE INSIDE OF THE RIGHT CHEEK. THE PATIENT HAS RECEIVED NERVE BLOCKS THAT ARE INADEQUATE IN PROVIDING PAIN RELIEF. THE PATIENT REPORTS SEEING A NEUROSURGEON FOR A NEUROSTIMULATOR IMPLANT TO TREAT PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Headache; Inadequate Pain Relief; Pain

  MAUDE report 10367770 ↗
• InjuryNov 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Extraskeletal ossification; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions; No Code Available; Pain; Scar Tissue

  MAUDE report 9365709 ↗
• InjuryNov 5, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE PATIENT WILL BE UNDERGOING A REVISION TO REMOVE THE LEFT TEMPOROMANDIBULAR JOINT AND FOSSA AND REPLACE THE DEVICE WITH A BILATERAL CUSTOM IMPLANT. THE SURGEON REPORTED THE CAUSE OF THE REVISION AS ATYPIC RAMUS ANATOMY ON THE LEFT SIDE WITH POOR FIT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 9280458 ↗
• InjuryOct 10, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Difficulty Chewing; Pain; Sleep Dysfunction

  MAUDE report 9177336 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

  Patient problems: Hematoma; Unspecified Infection

  MAUDE report 8692618 ↗