BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACUFIX

    MDR report key: 954836 · Received April 27, 2007

    Report

    Report Number
    1649384-2007-00026
    Event Type
    Malfunction
    Date Received
    April 27, 2007
    Date of Event
    March 23, 2007
    Report Date
    April 27, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT THAT IS REUSABLE. THE INVESTIGATION CONSISTED OF AN ANALYSIS OF THE RETURNED INSTRUMENT, AND A REVIEW OF PRODUCT LABELING AND THE DEVICE HISTORY RECORD FOR THE LOT. THE INVESTIGATION DETERMINED THE DEVICE MET PRODUCT SPECIFICATIONS. THE INSPECTION OF THE PRODUCT FOUND THAT THE DRIVER BROKE FROM A SIDEWAYS FORCE THAT BENT THE TIP. THE INVESTIGATION CONCLUDED THAT THE PRODUCT MALFUNCTIONED DUE TO USE ERROR BASED ON THE ANALYSIS OF PRODUCT LABELING AND THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    IN 2007, A PATIENT WAS UNDERGOING REVISION SURGERY OF THE CERVICAL SPINE TO ADDRESS DISC DISEASE AT AN ADJACENT LEVEL. DURING THE REVISION SURGERY, THE THREADED SCREW REMOVAL DRIVER BROKE WHEN THE SURGEON HAD DIFFICULTY REMOVING THE IMPLANTED SCREWS. THE BROKEN PORTION OF THE DRIVER WAS REMOVED BY THE SURGEON WITHOUT INJURY TO THE PATIENT. BECAUSE THE SURGEON HAD DIFFICULTY REMOVING THE SCREWS, HE DID NOT EXPLANT THE OTHER HARDWARE, BUT COMPLETED THE CASE BY INSERTING GRAFT IN THE DISEASED DISC SPACE. THERE WAS REPORTEDLY A 1 HOUR DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFIX THREADED SCREW REMOVAL DRIVER HXX ABBOTT SPINE, INC. NA 34ML

    Patients

    Seq Age Sex Outcome Treatment
    1 YR