BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVERWATCH

    MDR report key: 11978438 · Received June 10, 2021

    Report

    Report Number
    3004893332-2021-00007
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 10, 2021
    Manufacturer
    SPINAL ELEMENTS, INC
    Product Code
    LXH
    UDI-DI
    00840916134686
    PMA / PMN Number
    K161842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR NOTES NO NONCONFORMITIES. THE DEVICE WAS RETURNED AND THE DRIVER TIP IS FRACTURED OFF AND IS MISSING. COMPLAINT IS CONFIRMED. DEVICE MEETS SPECIFICATION EXCEPT FOR THE MISSING TIP. ROOT CAUSE IS UNKNOWN, BUT OSTEOSCLEROTIC BONE AND/OR EXCESSIVE FORCE CAN RESULT IN DEVICE TIP FRACTURING.

    Description of Event or Problem · 1

    WHILE DRIVING THE PEDICLE BONE SCREW, REPORTEDLY THE DRIVER TIP FRACTURED AND REMAINED IN THE HEAD OF THE SCREW SHANK. LEVELS BEING TREATED WERE L1-S1. THOUGH THE DRIVER TIP WAS IDENTIFIED, THE SURGEON ELECTED TO LEAVE THE DRIVER TIP AND THE SCREW IN PLACE. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876877 OVERWATCH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SPINAL ELEMENTS, INC 108-107-01-S 200431 00840916134686

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR