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
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 0002031049-2023-00047
• Device Sequence Number: 7200609
• Product Code: LZD
• UDI-Device Identifier: 07613327626650
• UDI-Public: 07613327626650
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 61-2006
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown