TMJ SYSTEM 99-6581Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841036057466), received between Mar 27, 2019 and Oct 6, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

  Patient problems: Erythema; Itching Sensation; Reaction; Unspecified Infection; Urticaria

  MAUDE report 10637467 ↗
• InjuryJul 13, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS TWO (2) YEARS AGO. THE PATIENT REPORTS THAT THE IMPLANTS ARE SITTING INCORRECTLY IN THE CONDYLES OF THE PATIENT¿S FACE, ARE SITTING TOO FAR BACK, AND ARE PRESSING ON THE EAR CANAL. THE PATIENT IS RECEIVING BOTOX FOR PAIN MANAGEMENT. THERE IS NO REVISION PLANNED AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Pain

  MAUDE report 10267618 ↗
• InjuryFeb 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION SURGERY DUE TO HETEROTOPIC BONE GROWTH AND DISLOCATION INVOLVING BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES. THE PATIENT WAS RECEIVED STOCK IMPLANTS OVER A DECADE AGO, AND CURRENTLY REPORTS LIMITED RANGE OF MOTION, HEADACHES, PAIN AND SWELLING. FIFTEEN MONTHS AGO, THE PATIENT REPORTED HETEROTOPIC OSSIFICATION IN THE JOINT AND IMPLANT DISLOCATION ON THE RIGHT SIDE. THIRTEEN MONTHS AGO, THE PATIENT REPORTED A REVISION SURGERY IN WHICH THE EXISTING IMPLANTS WERE RE-POSITIONED. TRIGGER POINT INJECTIONS AND NERVE BLOCKS HAVE BEEN INADEQUATE REGARDING PAIN MANAGEMENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Extraskeletal ossification; Headache; Inadequate Pain Relief; Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 9677239 ↗
• InjuryJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE DUE TO AN UNKNOWN REASON. STOCK MANDIBLE AND FOSSA IMPLANTS WERE REMOVED AND REPLACED WITH NEW STOCK IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9569618 ↗
• InjuryApr 1, 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: No Information

  MAUDE report 8470524 ↗
• InjuryMar 27, 2019Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 8455669 ↗