TMJ SYSTEM 99-6579Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00841036057459), received between Apr 1, 2019 and Feb 4, 2021 — classified as 19 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Discomfort; Limited Mobility Of The Implanted Joint; Pain; Swelling; Unspecified Infection

  MAUDE report 11278222 ↗
• InjuryNov 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT IS EXPERIENCING PAIN AND DIFFICULTY CHEWING ELEVEN (11) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. THE PATIENT INDICATES THAT THE PAIN IS BETTER THAN BEFORE THE SURGERY BUT IS STILL BEING EXPERIENCED. THE PATIENT REPORTS THAT THEIR JAW HAS SHIFTED SO THAT THEIR TEETH DO NOT TOUCH, AND AS A RESULT THE PATIENT CANNOT CHEW OR TEAR MEAT. THE PATIENT HAS BROKEN SEVERAL TEETH DUE TO BRUXISM AND THEIR DENTIST BELIEVES THE BREAKAGES ARE DUE TO TRAUMA FROM THE INITIAL SURGERY. THE PATIENT RECEIVES BOTOX SHOTS FOR BURNING OR FIRING NERVES THAT CAUSE PAIN. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Difficulty Chewing; Loss of Range of Motion; Pain

  MAUDE report 10791435 ↗
• InjuryOct 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS THREE (3) YEARS AGO. IMMEDIATELY FOLLOWING IMPLANTATION, THE PATIENT DEVELOPED BELL¿S PALSY ON THE RIGHT SIDE AND WAS INFORMED BY THE SURGEON THAT IT WAS A POSSIBLE REACTION TO THE SURGERY. THE PATIENT HAS USED A BITE SPLINT FOR THREE (3) YEARS TO ALIGN THE BITE. THE PATIENT HAD A ROOT CANAL A COUPLE MONTHS AGO AND THE ENDODONTIST TOOK CONE BEAM IMAGING. BASED ON THE IMAGING, THE ENDODONTIST BELIEVES THE DEVICE IS RUBBING THE BONE AND THAT THE SPLINT INCREASES THE PAIN. THE PATIENT HAS AN UNSPECIFIED ONE (1) INCH DEFORMITY IN THE JAW. THE PATIENT UNDERWENT A DRY NEEDLING TREATMENT ONE (1) YEAR AGO THAT DID NOT PROVIDE ADEQUATE PAIN RELIEF. THE PATIENT WISHES TO GET A REFERRAL TO A NEUROLOGIST TO SEE IF A SCREW IS POTENTIALLY HITTING A NERVE. THE PATIENT IS CURRENTLY RECEIVING BOTOX SHOTS IN THE JAW FROM THEIR DENTIST IN ORDER TO TRY TO RELAX THE MUSCLES. THE PATIENT IS NOT INTERESTED IN A REVISION SURGERY UNLESS IT WOULD BRING PAIN RELIEF. THE PATIENT HAS BEEN TOLD BY AN ORAL SURGEON THAT THE PATIENT HAS EXPERIENCED TOO MUCH BONE LOSS TO UNDERGO ADDITIONA

  Patient problems: Facial Nerve Paralysis; Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 10689178 ↗
• InjurySep 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 10590421 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN OPERATION TO CLEAN OUT HER JOINT APPROXIMATELY NINE (9) YEARS FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10364393 ↗
• 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 10267557 ↗
• InjuryJun 26, 2020Fracture; Fracture

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

  Patient problems: Foreign Body In Patient

  MAUDE report 10200732 ↗
• InjuryJun 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A SCAR TISSUE REMOVAL PROCEDURE AND CURRENTLY UNDERGOES PAIN MANAGEMENT FOLLOWING IMPLANTATION OF BILATERAL TEMPOROMANDIBULAR JOINT IMPLANTS TWELVE YEARS AGO. THE PATIENT REPORTED A SCAR TISSUE REMOVAL PROCEDURE TWO (2) YEARS AGO. THE PATIENT ATTENDS A PAIN MANAGEMENT CONSULT EVERY SIX (6) TO EIGHT (8) WEEKS. THE PATIENT HAS PREVIOUSLY RECEIVED CORTISONE SHOTS AND IS CURRENTLY ON BOTOX SHOTS, CELEBREX AND OXYCODONE. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Inadequate Pain Relief; Pain; Scar Excision; Scar Tissue

  MAUDE report 10112187 ↗
• InjuryMar 10, 2020Migration or Expulsion of Device; Material Integrity Problem; Migration or Expulsion of Device; Material Integrity Problem

  IT WAS REPORTED THE PATIENT HAS EXPERIENCED MULTIPLE ISSUES WITH HER BILATERAL TEMPOROMANDIBULAR JOINT PROSTHESES SINCE IMPLANTATION THIRTEEN YEARS AGO. THE PATIENT REPORTED SYMPTOMS AND PROCEDURES INCLUDING NERVE DAMAGE, NEUROMA REMOVAL, X-RAYS, BOTOX INJECTIONS, CT SCAN, PAIN, DIFFICULTY CHEWING, DIFFICULTY EATING AND A PLANNED REVISION. THE PATIENT REPORTED THE NERVE DAMAGE OCCURRED IMMEDIATELY AFTER IMPLANTATION WHICH RESULTED IN HER BEING UNABLE TO BLINK HER RIGHT EYE OR MOVE HER RIGHT EYEBROW. THE PATIENT REPORTED A NEUROMA WAS REMOVED FROM THE RIGHT SIDE OF HER JAW SEVEN YEARS AGO. THE PATIENT REPORTED SHE HAD X-RAYS TAKEN BY A DENTIST AND WAS INFORMED THAT A SCREW ON THE RIGHT SIDE IS NOT INTACT. THE PATIENT REPORTED RECEIVING BOTOX TO HER FACE APPROXIMATELY ONE YEAR AGO TO TREAT PAIN, BUT STATED THAT IT DID NOT PROVIDE RELIEF AND AGGRAVATED THE PAIN FURTHER. THE PATIENT REPORTED A CT SCAN WAS TAKEN FOUR MONTHS AGO AND REVEALED THAT TWO SCREWS ON THE RIGHT SIDE WERE NOT INTACT AND WERE NOT STABLE. THE PATIENT REPORTED SHE HAS EXCRUCIATING PAIN, DIFFICULTY CHEWING, AND DIFFICULTY EATING. SHE STATED DUE TO THE DIFFICULTY EATING, SHE CHOKES ON HER FOOD. ADDITIONALLY, SHE REPOR

  Patient problems: Difficulty Chewing; Facial Nerve Paralysis; Feeding Problem; Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 9811096 ↗
• 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 9677255 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT UNDERWENT A BILATERAL REVISION OF TEMPOROMANDIBULAR JOINT PROSTHESES DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9592257 ↗
• InjuryJan 10, 2020Fracture; Fracture

  IT WAS REPORTED A SCREW FRACTURED UPON INSERTION DURING IMPLANTATION OF A TEMPOROMANDIBULAR JOINT PROSTHESIS. THE FOSSA ALREADY HAD TWO SCREWS INSERTED, AND THE TWO ALREADY INSERTED SCREWS WERE REMOVED TO FACILITATE REMOVAL OF THE PIECE OF THE FRACTURED SCREW. SOME OF THE BONE AROUND THE FRACTURED SCREW HAD TO BE MILLED AROUND THE SCREW TO ALLOW PLIERS TO GRIP THE SHAFT OF THE FRACTURED SCREW. THE FRACTURED SCREW WAS REMOVED RESULTING IN A DELAY OF AROUND TWENTY MINUTES. THE FIELD WAS THEN FILLED WITH A RESCUE SCREW AND THE IMPLANTATION SURGERY WAS SUCCESSFULLY COMPLETED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9574271 ↗
• 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 9569627 ↗
• 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 9365718 ↗
• InjuryOct 25, 2019Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS REPORTED THE PATIENT COMPLAINED OF PAIN AND OPEN LOCK JAW APPROXIMATELY FOUR MONTHS PRIOR TO THE REVISION SURGERY. A SURGICAL EXPLORATION AND JOINT REPLACEMENT WAS PERFORMED, AND THE SURGEON NOTED THERE WERE NO VISIBLE DEFECTS TO THE HARDWARE, JUST A LOT OF SCAR TISSUE.

  Patient problems: No Code Available; Pain

  MAUDE report 9242027 ↗
• InjuryOct 10, 2019Fracture; Fracture

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

  Patient problems: No Code Available

  MAUDE report 9177392 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED NERVE DAMAGE AND NUMBNESS AFTER IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS. THE PATIENT DESCRIBED NUMBNESS ON THE RIGHT BOTTOM OF THEIR JAW AND LOSS OF FACIAL EXPRESSION. THE PATIENT SAID THEY ARE ONLY RECENTLY ABLE TO CLOSE THEIR EYES. THE PATIENT CURRENTLY RECEIVES BOTOX INJECTIONS INTO THEIR FOREHEAD TO HELP TREAT THE ISSUES ASSOCIATED WITH THE NERVE DAMAGE. THE PATIENT REPORTED THEIR SURGEON STATED THAT THE CONDITION IS LIKELY PERMANENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Nerve Damage; Numbness

  MAUDE report 8867884 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO REPOSITION TEMPOROMANDIBULAR IMPLANTS DUE TO NECROSIS AND BEING TOO CLOSE TO THE EAR CANAL. IMPLANTS REMAIN IMPLANTED. THE PATIENT EXPERIENCED NUMBNESS ON THE RIGHT BOTTOM OF THEIR JAW AND LOSS OF FACIAL EXPRESSION THAT HAS NOT RESOLVED FOLLOWING THE REPOSITIONING OF THE IMPLANTS. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Necrosis; Nerve Damage; Numbness

  MAUDE report 8867867 ↗
• 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 8470513 ↗