MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS UNKNOWN_CMF_PRODUCT; IMPLANT

Catalog Number UNK_CMF

Device Problem Fracture (1260)

Patient Problem Inadequate Osseointegration (2646)

Event Date 12/21/2023

Event Type  Injury  

Event Description

It was reported that during a revision surgery, the screws were discovered to be broken.It was able to be removed successfully.

Manufacturer Narrative

The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.

Manufacturer Narrative

Corrected data: it was determined after receiving further clarification from the customer and the log files from the device, this event for this product was not a reportable event per cfr 21, part 803.This supplemental is being filed to identify an mdr was not required for this event, for this product.

Event Description

It was reported that during a revision surgery, the screws were discovered to be broken.It was able to be removed successfully.

• Brand Name: UNKNOWN_CMF_PRODUCT
• Type of Device: IMPLANT
• 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: 18547710
• MDR Text Key: 333313849
• Report Number: 0002031049-2024-00006
• 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: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UNK_CMF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: No
• 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