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

Model Number TYY-NNNM

Device Problem Insufficient Information (3190)

Patient Problem Joint Disorder (2373)

Event Type  Injury  

Manufacturer Narrative

This patient received bilateral tmj implants in (b)(6) 2011.The left tmj devices were removed for an unknown reason.Investigation of removal is still pending.This mdr will be updated once additional information is received.

Event Description

The patient's left tmj devices were removed for an unknown reason.

• 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: 8898084
• MDR Text Key: 154457539
• Report Number: 2031049-2019-00032
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2013
• Device Model Number: TYY-NNNM
• Device Catalogue Number: TYY-NNNM
• Device Lot Number: W19620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention