MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BONE SCREW 2.0MM X 6MM; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

Catalog Number 61-2006

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Inadequate Osseointegration (2646)

Event Date 05/31/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported there was device and screw issues post op and a revision surgery was performed.During the revision surgery it was discovered the device and screw was loose.

Event Description

It was reported there was device and screw issues post op and a revision surgery was performed.During the revision surgery it was discovered the device and screw was loose.

Manufacturer Narrative

Stryker¿s clinical consultant and the engineering department reviewed the ct scan together.They confirmed the 2nd screw from the posterior was loose.Therefore, the reported event (screw loosening) could be confirmed.In conclusion, the patient had a trauma and her discomfort had started after that.The surgeon reported screw loosening, infection symptoms, and low bone quality.Additional surgery showed the bone screw became loose after the trauma and the surgeon removed that screw.If further information becomes available, the investigation will be re-evaluated.

• Brand Name: TMJ BONE SCREW 2.0MM X 6MM
• 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: 17171887
• MDR Text Key: 317570634
• Report Number: 0002031049-2023-00047
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 61-2006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/31/2023
• Initial Date FDA Received: 06/21/2023
• Supplement Dates Manufacturer Received: 05/31/2023
• Supplement Dates FDA Received: 08/23/2023
• 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