Patient-Fitted TMJ Reconstructive Prosthesis System 65-2006Recalls & reported problems
TMJ Solutions, Inc. · 2.0 x 6 mm Self-Tapping Bone Screw, 5 Pack · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327626711), received between Mar 21, 2025 and Sep 15, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.
Reports received per month
Most reported problems
Device problems
- Inadequacy of Device Shape and/or Size1
- Loss of Osseointegration1
- Nonstandard Device1
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Inadequate Osseointegration1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Inadequacy of Device Shape and/or Size
It was reported that the fossa component could not be properly seated intraoperatively on either the bone or the manufacturing model. The component was unstable and rocked, requiring modification of the surrounding bone to achieve acceptable seating. Postoperative imaging showed areas where full adaptation was not achieved. In addition, remarks were reported regarding screw selection.
Patient problems: Insufficient Information
MAUDE report 50768323 ↗MalfunctionAug 20, 2025Loss of Osseointegration; Loss of Osseointegration
IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO THE LOSS OF MULTIPLE SCREWS IN BOTH THE FOSSA AND RAMUS FIXTURES, WHICH RESULTED FROM UNUSUAL PRESSURE ON THE PROSTHESIS.
Patient problems: Inadequate Osseointegration
MAUDE report 22854770 ↗InjuryMar 21, 2025Use of Incorrect Control/Treatment Settings; Nonstandard Device; Use of Incorrect Control/Treatment Settings; Nonstandard Device
IT WAS REPORTED THAT MANUAL FOSSA PRODUCTION IGNORED INSTRUCTIONS TO AVOID THIN BONE, RESULTING IN AN INCORRECT SCREW LENGTH AND A SCREW IN THE CRANIAL VAULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662976 ↗
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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