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

Catalog Number CHG010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 03/22/2021

Event Type  Injury  

Event Description

It was reported the patient developed a skin lump around the left fossa and a hole straight to the fossa.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.

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 the patient developed a skin lump around the left fossa and a hole straight to the fossa.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.

Manufacturer Narrative

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

• Brand Name: TMJ UNILATERAL 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: stephani herbert ; 6059 king drive; ventura 93003 ; 8056503391
• MDR Report Key: 13047826
• MDR Text Key: 285158789
• Report Number: 0002031049-2021-00086
• 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
• 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 Catalogue Number: CHG010
• Device Lot Number: T19-0007
• 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
• Patient Outcome(s): Required Intervention