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

Model Number	TYY-NNNLF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Unspecified Infection (1930); Swelling (2091)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This patient received left tmj implants in (b)(6) 2012.The patient developed recurrent pain and swelling.The surgeon removed the devices and placed a spacer in the joint space.He reported that there was ankylosis over prosthesis.Multiple mdr reports were filed for this event; please see associated report ( 20301019-2020-00020).
Event or Problem Description
The patient's left tmj devices were removed due to recurrent pain and swelling.
Additional Manufacturer Narrative
The surgeon informed the manufacture that the patient had nine months of recurrent pain and swelling before the removal surgery that he believes was due to low-grade infection.He said that the device was stable but he found fluid around the device.However, microbiology results yielded no growth.
Event or Problem Description
The patient's left tmj devices were removed due to a suspected infection.

• Brand Name: PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
• Common Device Name: LEFT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura,
• MDR Report Key: 9919035
• Report Number: 2031049-2020-00019
• Device Sequence Number: 14270797
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLF0
• UDI-Public: +B004TYYNNNNLF0/$$3140501W22727
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: 05/01/2014
• Device Model Number: TYY-NNNLF
• Device Catalogue Number: TYY-NNNLF
• Device Lot Number: W22727
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 04/20/2020
• 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: 34 YR