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

Catalog Number CHG010

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2023

Event Type  Injury  

Event Description

It was reported that during placement of the implant, it was noticed it did not fit properly.There will be a second surgery performed with a new implant.

Manufacturer Narrative

Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.

Manufacturer Narrative

The event can be confirmed as the surgeon sent an image that showed the left mandibular component was not implanted.Moreover, a new order for the left mandibular component was submitted.On the date of the surgery, the surgeon could not implant the left mandibular component due to the changes in the patient¿s anatomy (the fossa component was implanted).The surgeon took a new scan and ordered a new mandibular component.The surgeon reported that the unusual delay between the planning medical grade ct scan, which was taken in (b)(6) 2022 after the first stage surgical procedure, and the eventual surgical implanting date in (b)(6) 2023 contributed to this event.This patient metabolically creates much heterotopic bone, which may have altered the mandibular anatomy on the lateral surface of the ramus to the point where the mandibular component no longer fits.

Event Description

It was reported that during placement of the implant, it was noticed it did not fit properly.There will be a second surgery performed with a new implant.

• 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: rylee koole ; 6059 king drive; ventura 93003 ; 8056503391
• MDR Report Key: 16931081
• MDR Text Key: 315209051
• Report Number: 0002031049-2023-00036
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CHG010
• Device Lot Number: 2206141017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2023
• 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