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

Model Number	TYY-NNNNLF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Drug Resistant Bacterial Infection (4553)
Date of Event	12/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient developed a draining fistula from the submandibular incision.Culture samples were taken and confirmed the presence of (b)(6).The surgeon plans to remove these devices, treat the infection, and place revision devices later ( 2031049-2020-00087).
Event or Problem Description
The patient's left tmj devices are infected, and pending for removal.
Event or Problem Description
The surgeon removed this patient's left tmj devices due to infection.
Additional Manufacturer Narrative
The surgeon plans to place revision left tmj devices once the infection is resolved.Multiple mdrs were submitted (2031049-2020-00087).

• Brand Name: PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
• Common Device Name: LEFT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 10709043
• Report Number: 2031049-2020-00086
• Device Sequence Number: 3259008
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLF0
• UDI-Public: +B004TYYNNNNLF0/$$3220101W54194
• 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
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

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: 01/01/2022
• Device Model Number: TYY-NNNNLF
• Device Catalogue Number: TYY-NNNNLF
• Device Lot Number: W54194
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/17/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/21/2020
• 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: 32 YR