Patient-Fitted TMJ Reconstructive Prosthesis System CHG024Recalls & reported problems
TMJ Solutions, Inc. · TMJ Unilateral Implant, oversized · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327626605), received between Mar 21, 2025 and Feb 27, 2026 — classified as 4 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (7 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 Device7
- Adverse Event Without Identified Device or Use Problem3
- Device Dislodged or Dislocated1
- Inadequacy of Device Shape and/or Size1
- Patient-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
- Unspecified Infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Fungal Infection1
- Insufficient Information1
- Joint Dislocation1
Recent adverse event reports
The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.
InjuryFeb 27, 2026Device Dislodged or Dislocated
MalfunctionFeb 26, 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 24455238 ↗MalfunctionFeb 26, 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 24455214 ↗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 24447092 ↗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 24446912 ↗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 24446903 ↗MalfunctionFeb 12, 2026Patient-Device Incompatibility
IT WAS REPORTED THAT PLACEMENT OF THE FOSSA COMPONENT WAS PROBLEMATIC. THE MANDIBLE FRACTURED DURING MANUAL CUTTING BY THE SURGEON, LEADING TO INADEQUATE FIT OF THE FOSSA COMPONENT.
Patient problems: Insufficient Information
MAUDE report 24323475 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719735 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard 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 23719713 ↗InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT HAS AN INFECTION.
Patient problems: Unspecified Infection
MAUDE report 23680821 ↗MalfunctionSep 25, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23144438 ↗InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT HAS BEEN REPORTED THAT A PATIENT'S MANDIBULAR IMPLANT WAS REMOVED FOR A DEHISCENCE WITH POSSIBLE FUNGAL INFECTION. FROM WHAT THE REP KNOWS SO FAR, THE DEHISCENCE WAS ABLE TO BE CLOSED WITHOUT ISSUE ONCE THE IMPLANT WAS REMOVED.
Patient problems: Fungal Infection; Unspecified Infection
MAUDE report 22357450 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO NEW INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21662982 ↗
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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