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

Model Number	TYY-NNNM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	05/15/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No additional information was provided.
Event or Problem Description
It was reported by the patient that she had an additional surgery to treat a dislocation.

• Brand Name: PATIENT-FITTED LEFT TMJ RECONSTRUCTION PROSTHESIS
• Common Device Name: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura, ca
• MDR Report Key: 10217841
• Report Number: 2031049-2020-00038
• Device Sequence Number: 3233691
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W30433
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

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: 08/01/2016
• Device Model Number: TYY-NNNM
• Device Catalogue Number: TYY-NNNM
• Device Lot Number: W30433
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 07/01/2020
• 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: 55 YR