BEUDAMED
    FDA Adverse Event Summary report: N

    2.0X10MM X-DRIVE SCREW

    MDR report key: 1335399 · Received February 24, 2009

    Report

    Report Number
    1032347-2009-00025
    Date Received
    February 24, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 11, 2009
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HWC
    PMA / PMN Number
    K081067
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. "INTRAOPERATIVE FRACTURE OF SCREWS CAN OCCUR IF EXCESSIVE FORCE (TORQUE) IS APPLIED WHILE SEATING BONE SCREWS." IF ADDITIONAL INFO IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE PLATING A MANDIBULAR FRACTURE, THE SCREW WAS SEATED AND THE DR TRIED TO TIGHTEN IT FURTHER, WHICH RESULTED IN THE HEAD OF A SCREW BREAKING OFF, WHILE THE SHAFT OF THE SCREW REMAINS IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.0X10MM X-DRIVE SCREW BONE SCREW HWC BIOMET MICROFIXATION, INC. * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * PART #.| SCREW WOULD HAVE BEEN USED WITH A PLATE, UNK WHICH