Patient-Fitted TMJ Reconstructive Prosthesis System CHG020Recalls & reported problems
TMJ Solutions, Inc. · TMJ Bilateral Implants · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This TMJ Solutions patient-fitted jaw joint implant has 174 adverse event reports, with no deaths and 136 injuries. The reports mostly describe infections, pain and swelling, implants moving out of position, and revision surgeries to replace them. Two recalls name this device, both open: one covers parts that may not fit the patient, causing a poor fit and an open bite, and the other covers a screw hole in the wrong position.
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
- 172
- Deaths reported
- 0
- Injuries reported
- 134
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 07613327626575), received between May 24, 2023 and Sep 29, 2026 — classified as 134 injuries, 38 malfunctions.
The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (27 reports).
2 FDA recall records name this device's identifier, 2 still open.
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
Recalls naming this device
- Feb 11, 2026Class IIOpen, Classified
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.
Z-2524-2026 · Root cause: Process control · Recall details · FDA record ↗
- Oct 13, 2025Class IOpen, Classified
Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.
Z-0488-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem81
- Device Appears to Trigger Rejection27
- Nonstandard Device26
- Device Dislodged or Dislocated24
- Inadequacy of Device Shape and/or Size11
- Malposition of Device9
- Fracture8
- Fitting Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Pain38
- Joint Dislocation35
- Unspecified Infection31
- Ankylosis21
- Bacterial Infection20
- Swelling/ Edema19
- Insufficient Information16
Recent adverse event reports
The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Inadequacy of Device Shape and/or Size
It was reported that it was questioned whether the increased vertical height was attributable to the fossa components rather than the mandibular component. No adverse consequences, surgical delay, or medical intervention were reported at intake.
Patient problems: Insufficient Information
MAUDE report 50929022 ↗InjurySep 17, 2026Device Appears to Trigger Rejection
It was reported that the right side will be revised due to infection.
Patient problems: Unspecified Infection
MAUDE report 50801696 ↗InjurySep 10, 2026Device Appears to Trigger Rejection
It was reported that the right side will be revised due to unknown reason.
Patient problems: Insufficient Information
MAUDE report 50714622 ↗InjurySep 2, 2026Fracture
Patient problems: Pain
MAUDE report 50558505 ↗InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE LEFT SIDE IS BEING REVISED DUE TO UNKNOWN REASON.
Patient problems: Insufficient Information
MAUDE report 25714819 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, A REVISION SURGERY IS NEEDED DUE TO AN INFECTION AFTER JOINT REPLACEMENT.
Patient problems: Unspecified Infection
MAUDE report 25688713 ↗InjuryJun 29, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE RIGHT JOINT NEEDS TO BE REVISED DUE TO UNKNOWN REASON.
Patient problems: Bacterial Infection; Fistula; Insufficient Information
MAUDE report 25651116 ↗InjuryMay 28, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE PATIENT HAS PAIN, ITCHING, REDNESS, SWELLING, AND A REVISION IS PLANNED.
Patient problems: Itching Sensation; Pain; Swelling/ Edema; Vertigo
MAUDE report 25315222 ↗InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem
SURGERY PLANNED FOR RIGHT TMJ JOINT DEBRIDEMENT AND POSSIBLE REPLACEMENT OF SCREWS.
Patient problems: Pain
MAUDE report 25228407 ↗InjuryMay 19, 2026Device Appears to Trigger Rejection
REVISION SURGERY NEEDED DUE TO INFECTION. DEVICES WILL BE REPLACED.
Patient problems: Unspecified Infection
MAUDE report 25217852 ↗InjuryMay 13, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT THE DEVICE WAS REMOVED AND IT WAS FRACTURED.
Patient problems: Bacterial Infection; Discomfort; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 25160872 ↗MalfunctionMay 11, 2026Patient Device Interaction Problem
IT WAS REPORTED THAT STARTING IN (B)(6) 2023, THE PATIENT REPORTED A SENSATION OF THE JAW MOVING ¿OUT OF ALIGNMENT,¿ ACCOMPANIED BY BITE DISTURBANCE, INCREASED PAIN AND EPISODES OF ¿LOCKING¿.
Patient problems: Joint locking; Loss of Range of Motion; Pain
MAUDE report 25135156 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT REQUIRED REVISION DUE TO HETEROTOPIC BONE FORMATION AND LIMITED PATIENT RANGE OF MOTION (ROM). A SURGICAL DELAY OF 30 MINUTES WAS REPORTED DURING IMPLANT REMOVAL.
Patient problems: Ankylosis; Loss of Range of Motion
MAUDE report 25134507 ↗InjuryMar 5, 2026Device Appears to Trigger Rejection
IT WAS REPORTED THAT A REMOVAL SURGERY IS NEEDED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 24523624 ↗InjuryMar 2, 2026Malposition of Device
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 24455212 ↗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 24455211 ↗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 24455210 ↗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 24446928 ↗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 24446923 ↗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 24446920 ↗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 24446919 ↗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 24446918 ↗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 24446917 ↗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 24446916 ↗
Other Joint, Temporomandibular, Implant devices
- 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
- 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 · each recall links to the FDA recall notice
- 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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