MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number CHG020

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Osteolysis (2377)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

Device not returned for evaluation as it was implanted.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported that due to radiation treatment for cancer, the patient's bone resorbed resulting in the device being displaced.This complaint was reviewed upon the acquisition of tmj solutions by stryker.There was a product malfunction which would be considered reportable based on stryker¿s determination of the potential severity for the reported event and based on the historical filing strategy on revision surgeries of cases of tmj solutions (now stryker).Based on this information, a report will be filed.

Manufacturer Narrative

Device not returned for evaluation as it was implanted.If additional information is received it will be reported on a supplemental report.

Event Description

It was reported that due to radiation treatment for cancer, the patient's bone resorbed resulting in the device being displaced.This complaint was reviewed upon the acquisition of tmj solutions by stryker.There was a product malfunction which would be considered reportable based on stryker¿s determination of the potential severity for the reported event and based on the historical filing strategy on revision surgeries of cases of tmj solutions (now stryker).Based on this information, a report will be filed.

• Brand Name: TMJ BILATERAL IMPLANTS
• Type of Device: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Manufacturer (Section D): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer (Section G): TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS; 6059 king drive; ventura 93003
• Manufacturer Contact: stephani herbert ; 6059 king drive; ventura 93003 ; 8056503391
• MDR Report Key: 13052779
• MDR Text Key: 286064293
• Report Number: 0002031049-2021-00087
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CHG020
• Device Lot Number: T15-571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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