Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNRMRecalls & reported problems
TMJ Solutions, Inc. · Right Mandibular Component · Class 3 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This TMJ Solutions right mandibular component is a patient-fitted implant used to rebuild the temporomandibular (jaw) joint. The 38 reports mostly describe ongoing pain, infection, swelling, and bone growing abnormally around or into the implant, with several cases where the component had to be removed and the joint cleaned or revised. No deaths were reported, and all 38 reports involved injuries. There are no recalls naming 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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI B004TYYNNNNRM0), received between Mar 14, 2018 and Sep 7, 2021 — classified as 38 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 Problem22
- Patient Device Interaction Problem5
- Loose or Intermittent Connection3
- Malposition of Device3
- Osseointegration Problem2
- Positioning Problem2
- Connection Problem1
- Difficult To Position1
Patient problems
- Unspecified Infection10
- Joint Disorder8
- Ankylosis5
- Hypersensitivity/Allergic reaction5
- Swelling/ Edema4
- Implant Pain3
- Inadequate Osseointegration3
- Bacterial Infection2
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT DEVELOPED HETEROTOPIC BONE AROUND THE RIGHT MANDIBULAR COMPONENT. THE SURGEON DEBRIDED THE JOINT.
Patient problems: Ankylosis; Implant Pain
MAUDE report 12437126 ↗InjuryJul 13, 2021Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem; Loss of Osseointegration; Adverse Event Without Identified Device or Use Problem
THE SURGEON REPORTED THAT THE PATIENT'S RIGHT RAMUS HAS RESORBED DUE TO A RARE BONE METABOLISM DISORDER.
Patient problems: Inadequate Osseointegration
MAUDE report 12163474 ↗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 12137438 ↗InjuryJun 2, 2021Loose or Intermittent Connection; Connection Problem; Osseointegration Problem; Loose or Intermittent Connection; Connection Problem; Osseointegration Problem
THE SURGEON REMOVED THE RIGHT MANDIBULAR COMPONENT, DEBRIDED THE JOINT, AND PLACED A MANDIBULAR REVISION DEVICE.
Patient problems: Inadequate Osseointegration
MAUDE report 11925683 ↗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 11773866 ↗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 11735551 ↗InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
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 11631639 ↗InjuryApr 7, 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 RIGHT MANDIBULAR COMPONENT WAS REMOVED AND REPLACED DUE TO MATERIAL SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11631327 ↗InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN UNKNOWN SURGEON REMOVED THE RIGHT MANDIBULAR COMPONENT.
Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy
MAUDE report 11248436 ↗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 11190264 ↗InjuryDec 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS HOSPITALIZED FOR A SUSPECTED INFECTION OF HER RIGHT TMJ MANDIBULAR COMPONENT.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 11051612 ↗InjuryDec 10, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
THE RIGHT MANDIBULAR COMPONENT WAS REPORTED LOOSE AND THE SURGEON ELECTED TO REMOVE THE DEVICE.
Patient problems: Inadequate Osseointegration
MAUDE report 10988330 ↗InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE RIGHT TMJ DEVICE DUE TO INFECTION.
Patient problems: Swelling/ Edema; Unspecified Infection
MAUDE report 10976399 ↗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 10929703 ↗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 10909521 ↗InjuryNov 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S RIGHT TMJ MANDIBULAR COMPONENT IS DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 10901629 ↗InjuryNov 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S RIGHT MANDIBULAR COMPONENT WAS REMOVED DUE TO HETEROTOPIC BONE AND REPLACED WITH A REVISION COMPONENT.
Patient problems: Ankylosis
MAUDE report 10833441 ↗InjuryNov 11, 2020Positioning Failure; Difficult to Insert; Positioning Problem; Positioning Failure; Difficult to Insert; Positioning Problem
THE SURGEON WAS UNABLE TO PLACE THESE REVISIONS TMJ MANDIBULAR DEVICES DUE TO THE PATIENT'S SEVERE FIBROSIS AND SCARRING OF THE SOFT TISSUE ENVELOPE AROUND BILATERAL TMJ IMPLANTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10826212 ↗InjurySep 8, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT'S RIGHT MANDIBULAR COMPONENT WAS REMOVED DUE TO SUSPECTED TO MATERIAL SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10505534 ↗InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE RIGHT MANDIBULAR COMPONENT WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 10476712 ↗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 10451703 ↗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 10314020 ↗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 10311742 ↗InjuryJul 21, 2020Installation-Related Problem; Installation-Related Problem
THE SURGEON WAS UNABLE TO PLACE THE BILATERAL MANDIBULAR COMPONENTS.
Patient problems: Joint Disorder
MAUDE report 10304432 ↗
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-NNNNLMTMJ Solutions, Inc. · Joint, Temporomandibular, Implant31 reports
- Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNRFTMJ Solutions, Inc. · Joint, Temporomandibular, Implant28 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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