BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7126298 · Received December 18, 2017

    Report

    Report Number
    3025141-2017-00322
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 27, 2017
    Manufacturer
    ACUMED LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MDRS ASSOCIATED WITH THIS EVENT: 3025141-2017-003221 DRIVER.

    Description of Event or Problem · 1

    DURING IMPLANTATION OF AN ACULOC 2 PLATE, THE TIP OF THE DRIVER BROKE OFF IN THE HEAD OF ONE OF THE LOCKING SCREWS. THE DRIVER TIP COULD NOT BE REMOVED AND REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906534 SCREW, FIXATION, BONE HWC ACUMED LLC

    Patients

    Seq Age Sex Outcome Treatment
    1