MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS BONE SCREW 2.0MM X 10MM, 5 PACK; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number	65-2010
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	01/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was a failing left side mandible fixation with lateral dislocation of the condyle.
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received, it will be reported on a supplemental report.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information: d6a, d6b, h6.Correction: d2a, d2b, d3, g1, h5.The reported event is confirmed based on the analysis of the patient scans provided for the planning of new unilateral left side implants.Bilateral tmj implants were placed but loosening and breakage of the left mandibular implant screws led to implant dislocation and malocclusion, prompting revision surgery.Investigation suggested heterotopic bone formation caused the left fossa implant to sit improperly, altering load forces and causing screw failure, but the exact root cause remains undetermined since the original devices were not returned for detailed analysis.Based on the investigation, there is no indication for an incorrectly working product or any design, material, or manufacturing-related issue.Therefore, no corrective and/or preventive actions are deemed necessary at this time.

• Brand Name: BONE SCREW 2.0MM X 10MM, 5 PACK
• Common Device Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Manufacturer (Section D): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer (Section G): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer Contact: elena drewenskus ; boetzingerstr. 41; freiburg D-791-11 ; GM D-79111 ; 7614888208
• MDR Report Key: 21303901
• Report Number: 0008010177-2025-00016
• Device Sequence Number: 8904018
• Product Code: LZD
• UDI-Device Identifier: 07613327626797
• UDI-Public: 07613327626797
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 65-2010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2025
• Supplement Date Received by Manufacturer: 01/10/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown