MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BONE SCREW 2.0MM X 8MM; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number 61-2008

Device Problems Fracture (1260); No Apparent Adverse Event (3189)

Patient Problems Joint Dislocation (2374); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2023

Event Type  Injury  

Event Description

It was reported that the scan showed the implant was dislocated and three screws were broken.There will be a revision surgery performed.

Manufacturer Narrative

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

Manufacturer Narrative

Update: h6.Correction: the device was not returned for evaluation.This complaint # (b)(4) (61-2008) has been entered, because this type of screw was listed in the tmj concepts plan (t18-0634).The broken screws reported were identified to be 61-2010 (complaint # (b)(4)) on the postoperative images.The type of screw (61-2008) of this current complaint has not been used in the case and therefore, it was considered to be concomitant and will be updated in the record.H3 other text : implanted.

Event Description

It was reported that the scan showed the implant was dislocated and three screws were broken.There will be a revision surgery performed.

• Brand Name: TMJ BONE SCREW 2.0MM X 8MM
• 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: 16870682
• MDR Text Key: 314579243
• Report Number: 0002031049-2023-00030
• 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: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 61-2008
• Device Lot Number: 61-2008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• 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