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

Model Number TYY-NNNM

Device Problem Break (1069)

Patient Problem Joint Disorder (2373)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

This patient received bilateral tmj implants in (b)(6) 2001.The surgeon reported that the patient was involved in a motorvehicle accident and suffered trauma to the patient's right side.The patient had a scan done in the emergency room and the doctor believes the patient has a fractured right fossa component.The device remains implanted at this time.

Event Description

The patient's right fossa component is fractured.

Manufacturer Narrative

The surgeon removed the patient's bilateral tmj implants, debrided both sides, and placed spacers bilaterally.The surgeon plans on placing revision components at a later date.

Event Description

The patient's bilateral tmj implants were removed due to significant heterotopic bone.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Type of Device: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer Contact: gregory rose ; 2233 knoll drive; ventura, CA 93003-7398 ; 8056503391
• MDR Report Key: 8404847
• MDR Text Key: 138271182
• Report Number: 2031049-2019-00009
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TYY-NNNM
• Device Catalogue Number: TYY-NNNM
• Device Lot Number: W03369
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR