Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNMRecalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI B004TYYNNNNM0), received between May 25, 2018 and Aug 26, 2021 — classified as 65 injuries.

The most frequently reported specific device problem is “Malposition of Device” (8 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT THE PATIENT'S DEVICES ARE DISLOCATED.

  Patient problems: Joint Dislocation

  MAUDE report 12375376 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAS REPORTEDLY DEVELOPED AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12368756 ↗
• InjuryJul 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON PERFORMED DEBRIDEMENT SURGERY TO RELEASE THE ANKYLOSIS.

  Patient problems: Ankylosis; Implant Pain; Loss of Range of Motion

  MAUDE report 12228992 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S TMJ DEVICES ARE BEING REMOVED AND REVISED DUE TO HETEROTOPIC BONE.

  Patient problems: Ankylosis

  MAUDE report 12215158 ↗
• InjuryJul 21, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S TMJ DEVICES WERE REMOVED DUE TO INFECTION AND MALPOSITION.

  Patient problems: Implant Pain; Loss of Range of Motion; Unspecified Infection

  MAUDE report 12207790 ↗
• InjuryJul 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED A DEHISCENCE IN THE TEMPORAL AREA.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 12188774 ↗
• InjuryJul 14, 2021Malposition of Device; Adverse Event Without Identified Device or Use Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S LEFT TMJ DEVICES ARE REPORTEDLY MALPOSITIONED.

  Patient problems: Implant Pain; Loss of Range of Motion

  MAUDE report 12170322 ↗
• InjuryJun 22, 2021Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT LEFT TMJ DEVICES WERE REMOVED DUE TO MALPOSITION SECONDARY TO CHRONIC MASTOIDITIS.

  Patient problems: Osteolysis

  MAUDE report 12041310 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED SEROSANGUINOUS FROM THE RIGHT EAR AND WAS TREATED WITH ANTIBIOTICS. THE DEVICES REMAIN IMPLANTED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 11991668 ↗
• InjuryJun 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS EXPERIENCING SEVERE PAIN AND SWELLING ON THE LEFT SIDE.

  Patient problems: Implant Pain; Swelling/ Edema

  MAUDE report 11953353 ↗
• InjuryMay 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON DEBRIDED JOINTS BILATERALLY DUE TO ANKYLOSIS.

  Patient problems: Ankylosis; Loss of Range of Motion; Pain

  MAUDE report 11898342 ↗
• InjuryMay 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON DEBRIDED THE PATIENT'S TMJ JOINTS BILATERALLY.

  Patient problems: Ankylosis; Loss of Range of Motion

  MAUDE report 11845802 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  THE SURGEON REMOVED THE PATIENT'S TMJ DEVICES DUE TO MATERIAL SENSITIVITY.

  Patient problems: Hypersensitivity/Allergic reaction; Pain

  MAUDE report 11739658 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REMOVED THE PATIENT'S TMJ DEVICES DUE TO INFECTION.

  Patient problems: Bacterial Infection; Implant Pain; Pain; Swelling/ Edema

  MAUDE report 11729439 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REPORTED THAT HE COULD NOT PLACE THESE BILATERAL DEVICES DUE TO THE PATIENT'S REMODELING OF THE PATIENT'S ANATOMY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11346755 ↗
• InjuryOct 8, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS UNABLE IMPLANT THESE BILATERAL TMJ DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10652928 ↗
• InjurySep 30, 2020Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO GET THE TMJ IMPLANT COMPONENTS INTO ACCEPTABLE POSITION DURING THE IMPLANT SURGERY AND CHOSE TO NOT IMPLANT THE DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10610843 ↗
• InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S RIGHT TMJ IMPLANTS WERE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 10242824 ↗
• InjuryJul 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON PERFORMED AN INCISION AND DRAINAGE ON THE PATIENT'S LEFT TMJ DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 10237300 ↗
• InjuryJul 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY THE PATIENT THAT SHE HAD AN ADDITIONAL SURGERY TO TREAT A DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 10217841 ↗
• InjuryMar 6, 2020Installation-Related Problem; Installation-Related Problem

  THE SURGEON WAS UNABLE TO PLACE THESE BILATERAL TMJ IMPLANTS.

  Patient problems: Joint Disorder

  MAUDE report 9800925 ↗
• InjuryMar 4, 2020Installation-Related Problem; Installation-Related Problem

  THE SURGEON WAS NOT ABLE TO PLACE THESE TMJ IMPLANTS DURING THE REVISION SURGERY.

  Patient problems: Joint Disorder

  MAUDE report 9788765 ↗
• InjuryMar 2, 2020Malposition of Device; Malposition of Device

  THE SURGEON PLANNED ON PLACING REVISION BILATERAL TMJ IMPLANTS DUE TO MALOCCLUSION.

  Patient problems: Joint Disorder

  MAUDE report 9777554 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGEON REMOVED SYNOVIAL ENTRAPMENT FROM THE PATIENT'S LEFT TMJ.

  Patient problems: Joint Disorder

  MAUDE report 9666838 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 9611776 ↗