BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW

    MDR report key: 24607275 · Received March 16, 2026

    Report

    Report Number
    3025141-2026-00104
    Event Type
    Injury
    Date Received
    March 16, 2026
    Date of Event
    December 1, 2025
    Report Date
    March 16, 2026
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TO DATE, THE DEVICE HAS NOT RETURNED FOR EVALUATION, THE ROOT CAUSE COULD NOT BE ESTABLISHED. ADDITIONAL REPORTING ON THIS EVENT WILL BE PROVIDED AS A FOLLOW UP REPORT IF MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REPRESENTATIVE, "S/P ORIF LEFT DISTAL RADIUS DOS (B)(6) 2025. PATIENT DENIED ANY FALLS FROM LAST VISIT BUT PRESENTED WITH HARDWARE PROBLEMS. POST OP X-RAY CONFIRMED BROKEN DISTAL SCREW. PATIENT KEPT IN CAST ADDITIONAL TWO WEEKS. NO PLANS FOR HWR AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665076 UNKNOWN SCREW SCREW, FIXATION, BONE HWC ACUMED, LLC NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other