MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT

Model Number	TYY-NNNLF
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Implant Pain (4561)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The patient's left fossa component is fractured.

• Brand Name: PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
• Common Device Name: LEFT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, LLC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 12374445
• Report Number: 2031049-2021-00058
• Device Sequence Number: 16445643
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLF0
• UDI-Public: +B004TYYNNNNLF0/$$3090401W11798
• 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: 2007
• 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): 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2009
• Device Model Number: TYY-NNNLF
• Device Catalogue Number: TYY-NNNLF
• Device Lot Number: W11798
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/26/2021
• 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; Required Intervention
• Patient Age: 61 YR