MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT

Model Number	TYY-NNNNM
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient was scheduled to receive bilateral revision tmj implants on (b)(6) 2020.The surgeon removed the existing devices (see mdr 2031049-2020-00011), and attempted to place the new implants, but was unable replicate his operative plan.Therefore, the surgeon placed spacers in the joint space and staged the patient.A new ct scan was taken of the patient, and new joints will be designed and produced without the presence of hardware.
Event or Problem Description
The surgeon was not able to place these tmj implants during the revision surgery.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Common Device Name: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura, ca
• MDR Report Key: 9788765
• Report Number: 2031049-2020-00012
• Device Sequence Number: 2650328
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W48201
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/04/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: TYY-NNNNM
• Device Catalogue Number: TYY-NNNNM
• Device Lot Number: W48201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 03/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR