Patient-Fitted TMJ Reconstructive Prosthesis System CHG010Recalls & reported problems
TMJ Solutions, Inc. · TMJ Unilateral Implant · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names 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 94 reports, including 72 injuries and no deaths. Common reports describe poor fit of guides and splints during surgery, screws coming loose, unwanted bone growth requiring revision, and infections. The 1 open recall, from October 2025, concerns screw holes in the wrong position on some implants. Reports rose from 15 in the prior 12 months to 31 in the latest 12 months.
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
- 94
- Deaths reported
- 0
- Injuries reported
- 71
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 07613327626551), received between May 30, 2023 and Sep 23, 2026 — classified as 71 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Nonstandard Device” (16 reports).
1 FDA recall record name this device's identifier, 1 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
- 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 Problem49
- Nonstandard Device16
- Device Appears to Trigger Rejection13
- Inadequacy of Device Shape and/or Size9
- Device Dislodged or Dislocated6
- Fracture6
- Patient-Device Incompatibility3
- Detachment of Device or Device Component2
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Unspecified Infection28
- Pain22
- Swelling/ Edema12
- Joint Dislocation10
- Ankylosis9
- Bacterial Infection9
- Insufficient Information8
Recent adverse event reports
The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Device Dislodged or Dislocated
It was reported that a revision surgery for a right side non-Stryker TMJ implant is required due to pain. During the revision planning of the non-Stryker TMJ implant on the right mandible, the surgeon observed that the contralateral left mandibular prosthesis was close to lateral dislocation due to a loose screw. The left-side implant was not the reason to request the revision surgery, since it does not create any symptoms for the patient and was considered as an incidental finding.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50864544 ↗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 50768321 ↗MalfunctionJul 14, 2026Malposition of Device
IT WAS REPORTED THAT TARGET OCCLUSION AND PROSTHESIS POSITION COULD NOT BE ACHIEVED AS PLANNED, RESULTING IN MALOCCLUSION.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 25809200 ↗InjuryJun 24, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING REVISION SURGERY, THE PLANNED EXPLANTATION OF THE MANDIBULAR COMPONENT WAS NOT POSSIBLE DUE TO BONE GROWTH, SO THE SURGICAL PLAN WAS CHANGED TO REMOVAL OF HETEROTOPIC BONE ONLY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: Ankylosis
MAUDE report 25606357 ↗InjuryJun 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT THE FOSSA COMPONENT SCREWS ARE COMING LOOSE.
Patient problems: Inadequate Osseointegration
MAUDE report 25514685 ↗InjuryMay 28, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT DISCREPANCIES CAUSED INACCURATE SURGICAL CUTS AND IMPROPER FIT OF THE TMJ AND CUSTOM PLATES, ULTIMATELY REQUIRING ABANDONMENT OF THE CUSTOM ORTHOGNATHIC PORTION TO ENSURE STABILITY AND ACCURATE JOINT POSITIONING.
Patient problems: Insufficient Information; Unspecified Musculoskeletal problem
MAUDE report 25315526 ↗MalfunctionMay 26, 2026Noise, Audible
IT WAS REPORTED THAT THE JOINT REPLACEMENT SQUEAKS, BUT THE PATIENT HAS NO PAIN OR OTHER PROBLEMS.
Patient problems: Discomfort; Unspecified Musculoskeletal problem
MAUDE report 25278853 ↗InjuryMar 2, 2026Device Appears to Trigger Rejection
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 24455058 ↗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 24447087 ↗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 24446927 ↗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 24446925 ↗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 24446924 ↗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 24446915 ↗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 24446910 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE TMJ DEVICES REQUIRE REVISION FOR AN UNKNOWN REASON.
Patient problems: Unspecified Musculoskeletal problem
MAUDE report 24377324 ↗InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE ORIGINAL IMPLANTS HAVE BEEN EXPLANTED AND A NEW REQUEST HAS BEEN CREATED.
Patient problems: Bacterial Infection; Fistula; Insufficient Information
MAUDE report 24258342 ↗InjuryDec 17, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO PLACE THE FOSSA COMPONENT AND DECIDED TO OMIT IT, PACKING THE JOINT WITH FAT INSTEAD. THE MANDIBULAR COMPONENT WAS SUCCESSFULLY IMPLANTED. A NEW FOSSA COMPONENT IS NEEDED.
Patient problems: Insufficient Information; Loss of Range of Motion
MAUDE report 23827575 ↗InjuryDec 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED THAT THE PATIENT HAD TO STAY IN HOSPITAL FOR FEW DAYS LONGER THAN NORMAL AS THE PROSTHESIS WAS NOT FITTING 100% DUE TO LACK OF SPLINTS AT THE SURGERY PHASE. BASED ON A POST OP CT SCAN OF THE PATIENT, THE MANDIBULAR PART IS ANGULATED SLIGHTLY FORWARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816125 ↗MalfunctionDec 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
THE CASE WAS NOT IMPLANTED BECAUSE THE SURGEON HAD CONCERNS REGARDING THE SCREW LOCATION. PREOPERATIVE IMPLANT PLANNING DOCUMENTS PROVIDED TO THE SURGEON INCLUDED A WARNING ABOUT THIS SCREW HOLE POSITION. AFTER REVIEWING THIS INFORMATION, THE SURGEON ELECTED NOT TO PROCEED WITH THE STRYKER IMPLANT AND USED AN ALTERNATIVE DEVICE. NO ADVERSE CONSEQUENCES WERE REPORTED FOR THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23816124 ↗InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO NEW INFORMATION.
Patient problems: Insufficient Information; Unspecified Infection
MAUDE report 23741830 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719824 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719786 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23719709 ↗MalfunctionDec 4, 2025Nonstandard Device; Nonstandard Device
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23716796 ↗
Other Joint, Temporomandibular, Implant devices
- Patient-Fitted TMJ Reconstructive Prosthesis System CHG020TMJ Solutions, Inc. · Joint, Temporomandibular, Implant2 recalls172 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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