MAUDE Adverse Event Report: TRIMED, INC. STRAIGHT PLATE,6-HOLE

Model Number	SP-6
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Foreign distributor reported on (b)(6) 2026 that a locking screw was implanted to fix the sp-6 plate but failed to lock into the plate (rx attached).It was stated that the surgeon replaced the plate with another sp-6 and re-used the same screws; fixation was successful.Therefore, she believes the defect is attributed to the thread of the original plate.It was reported that the device came in contact with the patient per planned procedure, there was over a 20-minute delay to swap out the plate however this did not cause any negative impact on the patient.

• Brand Name: STRAIGHT PLATE,6-HOLE
• Common Device Name: STRAIGHT PLATE,6-HOLE
• Manufacturer (Section D): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer (Section G): TRIMED, INC.; 27533 avenue hopkins; santa clarita CA 91355
• Manufacturer Contact: megan rissler ; 27533 avenue hopkins; santa clarita, CA 91355 ; 6612557406
• MDR Report Key: 24985679
• Report Number: 2031009-2026-00004
• Device Sequence Number: 9642936
• Product Code: HRS
• UDI-Device Identifier: 00842188120121
• UDI-Public: 00842188120121
• Combination Product (Y/N): N
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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 Model Number: SP-6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown