BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXLINK

    MDR report key: 954838 · Received April 27, 2007

    Report

    Report Number
    1649384-2007-00024
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    March 27, 2007
    Report Date
    April 20, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT LOT NUMBER AND PART HAVE NOT BEEN MADE AVAILABLE TO ABBOTT SPINE. DEVICE IS AN INSTRUMENT. INVESTIGATION IS PENDING.

    Description of Event or Problem · 1

    IN 2007, A PATIENT UNDERWENT POSTERIOR CERVICAL FUSION. DURING THE SURGERY, THE NEXLINK SET SCREW DRIVER BROKE AS THE SURGEON WAS TRYING TO REATTACH THE CLOSURE TOP. THE TIP OF THE DRIVER WAS REMOVED AND THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXLINK NEXLINK SET SCREW DRIVER KWP ABBOTT SPINE, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR