BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUFIX

    MDR report key: 865582 · Received June 15, 2007

    Report

    Report Number
    1649384-2007-00103
    Event Type
    Injury
    Date Received
    June 15, 2007
    Date of Event
    May 7, 2007
    Report Date
    June 15, 2007
    Manufacturer
    ABBOTT SPINE, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PLATE IMPLANTED, SWIVEL EXPLANTED. DEVICE INVESTIGATION IS PENDING. MFR DATE IS UNK, PLATE LOT# WAS NOT PROVIDED.

    Description of Event or Problem · 1

    IN 2007 DURING A 3 LEVEL ACDF, WHEN THE SURGEON WAS IMPLANTING A SCREW TO SECURE AN ACUFIX PLATE, THE SECURE RING LOCKING MECHANISM OF THE PLATE DETACHED. THE SURGEON ATTEMPTED TO REIMPLANT THE SECURE RING WITH THE SCREW AND THE SECURE RING FELL OFF THE END OF THE SCREW. THE SURGEON REMOVED THE SWIVEL AND IMPLANTED THE SCREW WITHOUT A LOCKING MECHANISM. THERE WAS NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACUFIX ACP 3 SEGMENT SLIMLINE HYBRID PLATE ASSEMBLY, 56 MM KWQ ABBOTT SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention