BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.4MM X 12MM HT X-DRIVE LOCKING RECON SCREW

    MDR report key: 1282023 · Received December 19, 2008

    Report

    Report Number
    1032347-2008-00074
    Event Type
    Other
    Date Received
    December 19, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 20, 2008
    Manufacturer
    BIOMET MICROFIXATION, INC.
    Product Code
    HWC
    PMA / PMN Number
    K980510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN, THEREFORE, A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    WHEN (B) (6) TRIED TO INSERT 85-2512 TO FIX THE PLATE, TWO SCREWS BROKE AND THE TIP OF THE SCREW REMAINED IN THE PATIENT'S BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM X 12MM HT X-DRIVE LOCKING RECON SCREW BONE SCREW HWC BIOMET MICROFIXATION, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREWS WERE USED WITH PLATE (25-4541)