Patient-Fitted TMJ Reconstructive Prosthesis System CHG026Recalls & reported problems
TMJ Solutions, Inc. · TMJ Bilateral Implants, oversized · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327626568), received between Nov 26, 2025 and Feb 25, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (4 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.
Reports received per month
Most reported problems
Device problems
- Nonstandard Device4
- Adverse Event Without Identified Device or Use Problem1
- Device Dislodged or Dislocated1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2026Nonstandard Device
WITHIN THE SCOPE EVALUATION FOR A PRODUCT FIELD ACTION, THIS CASE WAS IDENTIFIED TO HAVE THE POTENTIAL TO EXHIBIT THE HAZARD OF THE RECOMMENDED SCREW LENGTH BEING GREATER THAN THE BONE THICKNESS FOR IMPLANTS WITH SCREW HOLES LOCATED IN AN AREA OF THIN BONE. NO ADVERSE CONSEQUENCES WERE REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24447082 ↗MalfunctionDec 8, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716814 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716343 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716338 ↗MalfunctionNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE SURGEON WAS NOT ABLE TO MOBILIZE THE MANDIBLE ENOUGH TO GET THE INTERMEDIATE SPLINT IN PLACE, AND THE LEFORT WAS NOT COMPLETED AS THEY WERE NOT SURE IF THEY WOULD GET THE CORRECT RESULT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 23656749 ↗
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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