2.4MM SYSTEM 91-2710Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00841036053642), received between Mar 6, 2019 and Nov 8, 2021 — classified as 36 injuries, 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K001238); they may or may not involve this specific model.

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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2021Malposition of Device; Malposition of Device

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770285 ↗
• 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 11278189 ↗
• 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 10791428 ↗
• InjuryNov 3, 2020Adverse Event Without Identified Device or Use Problem; Noise, Audible; Adverse Event Without Identified Device or Use Problem; Noise, Audible

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

  Patient problems: Discomfort; Hearing Loss; Pain; Rupture

  MAUDE report 10777365 ↗
• InjuryOct 28, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

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

  Patient problems: Inadequate Pain Relief; Nerve Damage; Pain

  MAUDE report 10747147 ↗
• 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 NOT INTERESTED IN A REVISION SURGERY UNLESS IT WOULD BRING PAIN RELIEF. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 10689175 ↗
• InjuryOct 6, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION TO REMOVE TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE DUE TO ALLERGIC REACTION EIGHT (8) MONTHS FOLLOWING IMPLANTATION. THE PATIENT REPORTS THERE WAS AN ALLERGY TEST PRIOR TO IMPLANTATION THAT CONFIRMED A NICKEL ALLERGY BUT THERE WAS NO INDICATION OF A TITANIUM ALLERGY AT THAT TIME. ONE (1) MONTH FOLLOWING IMPLANTATION, THE PATIENT EXPERIENCED REDNESS, ITCHING AND HIVES ON THE JAW, EAR, THROAT AND NECK. A TITANIUM ALLERGY WAS CONFIRMED APPROXIMATELY TWO (2) MONTHS FOLLOWING IMPLANTATION. THE PATIENT WAS PRESCRIBED NINE (9) MEDICATIONS TO TREAT A REPORTED FACIAL INFECTION. THE PATIENT IS CURRENTLY ON IV MEDICATION FOR EIGHT (8) WEEKS FOLLOWING AN EYE REACTION THAT OCCURRED FOLLOWING THE REMOVAL OF THE IMPLANT. THE PATIENT IS DISCUSSING IMPLANT REPLACEMENT OPTIONS WITH THEIR SURGEON. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

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

  MAUDE report 10637402 ↗
• 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 10590382 ↗
• InjuryAug 31, 2020Adverse 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: Unspecified Infection

  MAUDE report 10472588 ↗
• InjuryAug 31, 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 FACIAL PAIN FOURTEEN (14) MONTHS FOLLOWING IMPLANTATION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE LEFT SIDE. THE PATIENT WAS DIAGNOSED WITH A LEFT EAR INFECTION AND TREATED WITH BACTRIM. THE PATIENT HAS ARTHRITIS ON BOTH SIDES OF THE MOUTH AND HAS PREVIOUSLY EXPERIENCED RUBBING OF THE JOINT. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Arthritis; Pain; Unspecified Infection

  MAUDE report 10472003 ↗
• 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 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 10367754 ↗
• InjuryJul 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

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

  MAUDE report 10318008 ↗
• 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 10267526 ↗
• InjuryJul 8, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT IS REPORTED THAT A SCREW IS PUSHING THROUGH A NERVE AND THE PATIENT IS EXPERIENCING PAIN AND NUMBNESS ON THE RIGHT FOLLOWING IMPLANTATION OF CUSTOM TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE. ANALYSIS OF POST-OPERATIVE SCANS TAKEN FIVE (5) DAYS FOLLOWING IMPLANTATION INDICATES THAT A SCREW IS POSITIONED AT THE ENTRANCE OF THE MANDIBULAR CANAL AND PROTRUDES 2MM THROUGH THE LINGUAL SIDE, PUSHING ON THE NERVE. THE PATIENT HAS BEEN PRESCRIBED CLONAZEPAM, AMITRIPTYLINE, CARBAMAZEPINE FOR THE TREATMENT OF NERVE PAIN. IF MEDICATION IS UNSUCCESSFUL IN CONTROLLING THE PATIENT¿S PAIN, A REVISION WILL BE PERFORMED TO REPLACE THE AFFECTED SCREW WITH A SCREW OF A DIFFERENT LENGTH. NO REVISION IS SCHEDULED AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Numbness; Pain

  MAUDE report 10246679 ↗
• 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 10112155 ↗
• InjuryMay 20, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: Sleep Dysfunction; Swelling

  MAUDE report 10075511 ↗
• InjuryApr 10, 2020Adverse 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: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 9949736 ↗
• InjuryApr 3, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

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

  Patient problems: Loss of Range of Motion; Pain; Scar Tissue

  MAUDE report 9920590 ↗
• 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 9811083 ↗
• InjuryMar 2, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Neurological Deficit/Dysfunction; Pain

  MAUDE report 9776530 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF TEMPOROMANDIBULAR IMPLANTS ON THE RIGHT SIDE DUE TO HETEROTOPIC BONE GROWTH. LEADING UP TO THE REVISION, THE PATIENT COMPLAINED OF INCREASED PAIN. DURING THE REVISION, EXCESS BONE GROWTH WAS REMOVED AROUND THE JOINT AND THE FOSSA COMPONENT WAS REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: Extraskeletal ossification; Pain

  MAUDE report 9706127 ↗
• 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 9677253 ↗
• 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 9592321 ↗
• InjuryJan 3, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  IT WAS REPORTED THE PATIENT MAY UNDERGO A REVISION OF TEMPOROMANDIBULAR JOINT IMPLANTS ON THE RIGHT SIDE AT A LATER UNSPECIFIED DATE DUE TO AN UNKNOWN REASON. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Increased Sensitivity; Limited Mobility Of The Implanted Joint; No Information; Pain

  MAUDE report 9546771 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT EXPERIENCED SKIN ISSUES, INFECTIONS, DISCOMFORT AND TROUBLE EATING. NO ADDITIONAL PATIENT CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: Autoimmune Reaction; Difficulty Chewing; Discomfort; Unspecified Infection

  MAUDE report 9546596 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K001238. One submission often covers many models, so check the product and lot details in each record.

• Z-0282-2009 · Jul 11, 2008 · Terminated
  HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures.