MAUDE Adverse Event Report: TRIMED, INC. VA LOCKING SCREW 3.5, 16MM, T15, TI

Model Number	TRXV3.5-16 T
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Burning Sensation (2146); Implant Pain (4561)
Date of Event	08/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A trimed sales rep located in the united states reported on (b)(6) 2020 that a screw (trxv3.5-16 t) had started backing out from the plate and bone of the patient.The screw and plate was originally implanted on (b)(6) 2020, the healing time for this plate and screw is about 6 weeks to complete fixation.In (b)(6) the patient started experiencing irritation at the implant site and where that screw was placed.An x-ray was taken of the implant and it was determined that one of the screws started to back out.The screw was then removed on (b)(6) 2020, the rest of the plate and screws were left in the patient as they were not causing any additional harm, and the rest of the construct was holding up.The surgeon noted that the joint was fused and fixation had been achieved, and stated the removal did not cause any additional harm to the patient.The screw was returned to trimed to aid in the investigation of the device.
Additional Manufacturer Narrative
Upon return and inspection of the device it was determined that the device had damaged threads likely causing the screw to not properly lock into the plate causing the screw to back out of the plate.

• Brand Name: VA LOCKING SCREW 3.5, 16MM, T15, TI
• Common Device Name: VA LOCKING SCREW 3.5, 16MM, T15, TI
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• MDR Report Key: 10557182
• Report Number: 2031009-2020-00004
• Device Sequence Number: 19509874
• Product Code: HWC
• UDI-Device Identifier: 00842188120688
• UDI-Public: 00842188120688
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K192696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: TRXV3.5-16 T
• Device Catalogue Number: TRXV3.5-16 T
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention