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

Catalog Number CHG020

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

Patient Problems Unspecified Infection (1930); Drug Resistant Bacterial Infection (4553)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

The surgeon prescribed antibiotic medication.It is still implanted.

Event Description

The surgeon did cultures of this area, and they were negative, but it appeared to be inflamed at the biopsy.The patient has grown (b)(6) out of her ear, which was near the site.

Event Description

The surgeon did cultures of this area, and they were negative, but it appeared to be inflamed at the biopsy.The patient has grown mrsa out of her ear, which was near the site.

Manufacturer Narrative

This reported infection could not be confirmed, as no evidence (e.G.Lab results or operative notes) were provided.The patient received tmj devices on (b)(6) 2018.The surgeon reported on (b)(6) 2021, that the patient ¿has developed a soft tissue infection near her implants¿.He reports that at first the patient had this response over the fossa component and most recently the patient is having it over the condyle or more body position.Further, he reports that cultures were taken, but were negative, and ¿the biopsy appears to be inflammatory¿.The surgeon had reached out to the engineering department initially asking if it is safe to do an mri angiogram in the area of the tmj components.At the time of the reported event, the devices were not reported to be removed.The surgeon reported that the infection was confirmed, but that he is ¿attempting abx¿ (antibiotics) first.No evidence (e.G.Lab results) of the infection was provided.Conclusively, the event (infection) cannot be confirmed and the root cause for the infection remains uncertain.The information received does not suggest a device failure, malfunction, or other performance issues.If further information becomes available, this report will be revised.

• 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: 12788916
• MDR Text Key: 280605994
• Report Number: 0002031049-2021-00065
• 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,Followup
• Report Date: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Catalogue Number: CHG020
• Device Lot Number: T18-0614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2018
• 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; Hospitalization
• Patient Age: 12 YR