MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT; RIGHT MANDIBULAR COMPONENT

Model Number	TYY-NNNNRM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ankylosis (4527)
Date of Event	11/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon released the ankylosis and reported that the implants appeared stable and secure.Multiple mdr's were submitted for this event(2031049-2020-00097).
Event or Problem Description
The surgeon removed the heterotopic bone formation on the right side.

• Brand Name: PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
• Common Device Name: RIGHT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 10909521
• Report Number: 2031049-2020-00098
• Device Sequence Number: 2895585
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRM0
• UDI-Public: +B004TYYNNNNRM0/$$3200101W43704
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/25/2020

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: 01/01/2020
• Device Model Number: TYY-NNNNRM
• Device Catalogue Number: TYY-NNNNRM
• Device Lot Number: W43704
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 11/26/2020
• 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: 50 YR