BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABC SCREW

    MDR report key: 563313 · Received January 14, 2004

    Report

    Report Number
    563313
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    January 8, 2004
    Report Date
    January 13, 2004
    Manufacturer
    AESCULAP, INC.
    Product Code
    HWC
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING AN ANTERIOR CERVICAL DISKECTOMY AND FUSION OF C4-5 AND C5-6, ONE OF THE TWO SCREWS BEING USED TO SECURE THE ABC PLATE BROKE. AS THE SURGEON ATTEMPTED TO TIGHTEN THE SCREW AT C4 ON THE PATIENT'S RIGHT, A PORTION OF THE SCREW BROKE OFF. THE SCREW WAS REMOVED AND A PORTION WAS RETRIEVED IN THE SUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABC SCREW 14MM CERVICAL SCREW HWC AESCULAP, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR NO OTHER THERAPIES