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

Model Number T17-0582

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

Patient Problem Implant Pain (4561)

Event Date 03/14/2018

Event Type  Injury  

Manufacturer Narrative

Patient has arthritis, fever, swelling and pain.Clinical consultant reviewed the ct scan and noted that the fossa component is not seated completely against the bone, contributing to the patient's issues.No material sensitivity is existent.No information if further treatment/surgery was performed.Still implanted.

Event Description

This complaint was reviewed upon the acquisition of tmj solutions by stryker.No product malfunction was reported, as the device appeared to work as intended.However, there was an adverse event, 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 (BUNDLED COST)
• 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: mo bakhshi dezfuli ; 6059 king drive; ventura 93003 ; 8056503391
• MDR Report Key: 13044033
• MDR Text Key: 282503365
• Report Number: 0002031049-2021-00082
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Model Number: T17-0582
• Device Catalogue Number: CHG020
• Device Lot Number: T17-0582
• 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
• Date Device Manufactured: 09/01/2017
• 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): Other
• Patient Age: 28 YR