Patient-Fitted TMJ Reconstructive Prosthesis System 61-2010Recalls & reported problems
TMJ Solutions, Inc. · 2.0 x 10 mm Self-Tapping Bone Screw · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327626742), received between Sep 5, 2023 and Sep 5, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Loss of Osseointegration” (1 report).
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
- Loss of Osseointegration1
Patient problems
- Joint Dislocation1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 5, 2023Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT THE SCREWS ARE LOOSE AND/OR BROKEN AND THE IMPLANT HAS SHIFTED CREATING A NEED FOR A REVISION SURGERY.
Patient problems: Joint Dislocation; No Clinical Signs, Symptoms or Conditions
MAUDE report 17686825 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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