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

Model Number	TYY-NNNNM
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient was scheduled to receive bilateral implants on (b)(6) 2020.At the time of this surgery, this surgeon stated that he was not able to advance the patient's mandible as planned due to his inability to mobilize the patient's soft tissue.The surgeon elected to place bilateral stock tmj devices from another manufacturer.
Event or Problem Description
It was reported that the surgeon was not able to get the tmj implant components into acceptable position during the implant surgery and chose to not implant the devices.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Common Device Name: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura CA 93003 7607
• MDR Report Key: 10610843
• Report Number: 2031049-2020-00083
• Device Sequence Number: 17098661
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W52593$
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2020

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: 06/01/2022
• Device Model Number: TYY-NNNNM
• Device Catalogue Number: TYY-NNNNM
• Device Lot Number: W52593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2020
• Initial Report FDA Received Date: 09/30/2020
• 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: Required Intervention
• Patient Age: 12 YR