Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNRFRecalls & reported problems
TMJ Solutions, Inc. · Right Fossa Component · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This TMJ Solutions patient-fitted prosthesis is a custom implant that replaces the jaw joint. The 28 reports mostly describe infection, pain, and the device being removed or revised, along with a few cases where a part broke or a connection loosened. No deaths were reported and 27 injuries were. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI B004TYYNNNNRF0), received between Jul 23, 2018 and Aug 25, 2021 — classified as 27 injuries, 1 malfunction.
The most frequently reported specific device problem is “Loose or Intermittent Connection” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem20
- Loose or Intermittent Connection3
- Fracture2
- Break1
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Malposition of Device1
Patient problems
- Unspecified Infection12
- Joint Disorder6
- Implant Pain4
- Ankylosis3
- Joint Dislocation3
- Swelling/ Edema3
- Abscess2
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO A SUSPECTED INFECTION.
Patient problems: Unspecified Infection
MAUDE report 12368725 ↗InjuryJul 8, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO PAIN.
Patient problems: Implant Pain; Insufficient Information
MAUDE report 12137459 ↗InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAS DEVELOPED HETEROTOPIC BONE ON THE RIGHT SIDE, WHICH REQUIRES DEBRIDEMENT SURGERY.
Patient problems: Ankylosis; Joint Dislocation
MAUDE report 12046522 ↗MalfunctionMay 25, 2021Fracture; Fracture
THE SURGEON REPORTED THAT THE PATIENT HAS HAD SEVERE PAIN SINCE IMPLANTATION BILATERALLY. ON CT SCAN, IT APPEARED THE FOSSA COMPONENT HAS FRACTURED.
Patient problems: Failure of Implant; Implant Pain
MAUDE report 11882282 ↗InjuryMay 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT TMJ DEVICES WERE REMOVED DUE TO HETEROTROPIC BONE.
Patient problems: Ankylosis; Implant Pain; Swelling/ Edema
MAUDE report 11773869 ↗InjuryApr 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Bacterial Infection
MAUDE report 11735550 ↗InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Bacterial Infection
MAUDE report 11631640 ↗InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO A FRACTURE IN THE PATIENT'S ZYGOMATIC ARCH.
Patient problems: Bone Fracture(s); Joint Dislocation; Nonunion/Delayed-union Bone Fracture
MAUDE report 11468054 ↗InjuryMar 1, 2021Fracture; Fracture
InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Fistula; Swelling/ Edema; Unspecified Infection
MAUDE report 11190263 ↗InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT FOSSA COMPONENT WAS REMOVED DUE TO INFECTION.
Patient problems: Abscess; Unspecified Infection
MAUDE report 11152628 ↗InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 10976402 ↗InjuryDec 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Abscess; Fistula; Unspecified Infection
MAUDE report 10929692 ↗InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE HETEROTOPIC BONE FORMATION ON THE RIGHT SIDE.
Patient problems: Ankylosis
MAUDE report 10909560 ↗InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT FOSSA COMPONENT WAS REMOVED DUE TO PAIN AND REVISED SURGERY.
Patient problems: Joint Disorder
MAUDE report 10505547 ↗InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10451695 ↗InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT FOSSA COMPONENT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10427110 ↗InjuryJul 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10338221 ↗InjuryJul 23, 2020Malposition of Device; Malposition of Device
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO MALPOSITION.
Patient problems: Joint Disorder
MAUDE report 10314040 ↗InjuryJul 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S BILATERAL TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10311764 ↗InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10253679 ↗InjuryJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10217818 ↗InjuryMay 4, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THE PATIENT'S RIGHT TMJ FOSSA WAS REMOVED DUE TO SCREW LOOSENING.
Patient problems: Joint Disorder
MAUDE report 10022756 ↗InjuryApr 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT TMJ DEVICES WERE REMOVED DUE TO A SUSPECTED INFECTION THAT WAS CAUSING PAIN AND SWELLING.
Patient problems: Swelling; Unspecified Infection
MAUDE report 9931644 ↗InjuryJul 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT'S RIGHT TMJ DEVICES DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 8812237 ↗
Other Joint, Temporomandibular, Implant devices
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG020TMJ Solutions, Inc. · Joint, Temporomandibular, Implant2 recalls172 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG010TMJ Solutions, Inc. · Joint, Temporomandibular, Implant1 recall94 reports
- TMJ SYSTEM 24-6563Biomet Microfixation, Inc · Joint, Temporomandibular, Implant89 reports
- TMJ SYSTEM 24-6562Biomet Microfixation, Inc · Joint, Temporomandibular, Implant76 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant65 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG010AMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant1 recall0 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNRMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant38 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNLMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant31 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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