Patient-Fitted TMJ Reconstructive Prosthesis System TYY-NNNNLMRecalls & reported problems
TMJ Solutions, Inc. · Left Mandibular Component · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This TMJ Solutions patient-fitted system is a custom implant that replaces the jaw joint. The 31 reports describe pain, swelling, allergic reactions to the metal, infection, and the joint popping out of place, and several patients had the left mandibular component taken out or replaced. All 31 reports involve injuries, with no deaths. No recalls name this device, and there have been no reports in the past 12 months.
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
- 31
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI B004TYYNNNNLM0), received between Mar 8, 2019 and Sep 16, 2021 — classified as 31 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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem23
- Patient Device Interaction Problem5
- Malposition of Device3
- Device Dislodged or Dislocated2
- Positioning Problem2
- Activation, Positioning or Separation Problem1
- Difficult to Insert1
- Installation-Related Problem1
Patient problems
- Hypersensitivity/Allergic reaction7
- Joint Dislocation6
- Unspecified Infection6
- Implant Pain3
- Joint Disorder3
- Bacterial Infection2
- Loss of Range of Motion2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Positioning Problem; Adverse Event Without Identified Device or Use Problem; Positioning Problem
THE PATIENT HAS DEVELOPED MALOCCLUSION. THE SURGEON PLANS TO REVISE THE DEVICES.
Patient problems: Insufficient Information
MAUDE report 12485757 ↗InjuryAug 16, 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 MANDIBULAR COMPONENT WILL BE REMOVED AND REVISED DUE TO THE PATIENT'S MALOCCLUSION SECONDARY TO FAILED LEFORT AND RIGHT SSO SURGERY ON THE OTHER SIDE.
Patient problems: Loss of Range of Motion; Malunion of Bone
MAUDE report 12329285 ↗InjuryJul 20, 2021Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem
THE PATIENT PRESENTED TO THE SURGEON WITH PAIN, REDNESS, AND SWELLING. THE PATIENT'S METAL ALLERGY TESTS (LTT) ARE POSITIVE FOR NICKEL SENSITIVITY.
Patient problems: Bacterial Infection; Hypersensitivity/Allergic reaction; Implant Pain; Swelling/ Edema
MAUDE report 12197726 ↗InjuryJun 9, 2021Adverse 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: Bacterial Infection; Implant Pain
MAUDE report 11971511 ↗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 11631319 ↗InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED AND REPLACED THE LEFT MANDIBULAR COMPONENT WITH AN ALL-TITANIUM DEVICE DUE TO MATERIAL HYPER SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 11375730 ↗InjuryFeb 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ MANDIBULAR COMPONENT WAS REMOVED DUE TO RECURRING DISLOCATION.
Patient problems: Joint Dislocation
MAUDE report 11341032 ↗InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CT IMAGING REVEALED THAT THIS PATIENT'S BILATERAL MANDIBULAR COMPONENTS HAD BEEN REMOVED AND REPLACED WITH TEMPORARY DEVICES.
Patient problems: Loss of Range of Motion; Muscle Weakness/Atrophy
MAUDE report 11248488 ↗InjuryJan 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE LEFT TMJ DEVICES WERE REMOVED DUE TO INFECTION.
Patient problems: Hematoma; Swelling/ Edema; Unspecified Infection
MAUDE report 11198290 ↗InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE LEFT TMJ DEVICES DUE TO PAIN.
Patient problems: Arthralgia; Implant Pain
MAUDE report 11158459 ↗InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE LEFT MANDIBULAR COMPONENT WAS REMOVED DUE TO INFECTION.
Patient problems: Abscess; Unspecified Infection
MAUDE report 11152676 ↗InjuryDec 21, 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 LEFT SIDE.
Patient problems: Ankylosis
MAUDE report 11052381 ↗InjuryDec 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON ELECTED TO REMOVE THE LEFT MANDIBULAR IMPLANT AT THE SAME TIME HE REMOVED THE MATING FRACTURED LEFT FOSSA COMPONENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10977608 ↗InjuryNov 25, 2020Malposition of Device; Malposition of Device
THE PATIENT'S LEFT TMJ MANDIBULAR COMPONENT IS DISLOCATED.
Patient problems: Joint Dislocation
MAUDE report 10901485 ↗InjuryNov 17, 2020Malposition of Device; Malposition of Device
THE SURGEON PLANS TO REVISE THIS PATIENT'S LEFT MANDIBULAR COMPONENT DUE TO DISLOCATION SECONDARY TO MALPOSITIONING.
Patient problems: Joint Dislocation
MAUDE report 10857505 ↗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 10826211 ↗InjuryOct 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT'S LEFT TMJ DEVICES ARE INFECTED AND PENDING REMOVAL.
Patient problems: Drug Resistant Bacterial Infection; Post Operative Wound Infection
MAUDE report 10709044 ↗InjuryAug 20, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE LEFT TMJ DEVICES WERE REMOVED DUE TO MATERIAL SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10435136 ↗InjuryJul 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE SURGEON REMOVED THE HETEROTOPIC BONE FROM THE PATIENT'S LEFT TMJ DEVICES.
Patient problems: Joint Disorder; Pain
MAUDE report 10348159 ↗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 10311739 ↗InjuryJul 21, 2020Installation-Related Problem; Installation-Related Problem
THE SURGEON WAS UNABLE TO PLACE THE BILATERAL MANDIBULAR COMPONENTS.
Patient problems: Joint Disorder
MAUDE report 10304435 ↗InjuryJul 20, 2020Patient Device Interaction Problem; Patient Device Interaction Problem
THE PATIENT'S LEFT MANDIBULAR COMPONENT WAS REMOVED AND REVISED DUE TO MATERIAL SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10298202 ↗InjuryJul 7, 2020Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
THE PATIENT'S LEFT TMJ MANDIBULAR COMPONENT WAS REVISED DUE TO MATERIAL SENSITIVITY.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 10243011 ↗InjuryJun 25, 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 10194980 ↗InjuryJun 24, 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 10192754 ↗
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-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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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