BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.3MM PILOT DRILL OSTEOPOWER,12MM

    MDR report key: 23526030 · Received November 11, 2025

    Report

    Report Number
    2027754-2025-00053
    Event Type
    Injury
    Date Received
    November 11, 2025
    Date of Event
    October 16, 2025
    Report Date
    November 11, 2025
    Manufacturer
    OSTEOMED, LLC
    Product Code
    KMW
    UDI-DI
    00845694006408
    PMA / PMN Number
    K971692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    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 THAT DURING SURGERY, A 220-0302 DRILL BIT BROKE, AND PART OF IT REMAINED INSIDE THE PATIENT, WHICH COULD NOT BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2545501 1.3MM PILOT DRILL OSTEOPOWER,12MM HANDPIECE, ROTARY BONE CUTTING KMW OSTEOMED, LLC 220-0302 00845694006408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other