BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTEVIEW ACPS SCREWDRIVER

    MDR report key: 1517945 · Received October 2, 2009

    Report

    Report Number
    3003855635-2009-00005
    Event Type
    Malfunction
    Date Received
    October 2, 2009
    Date of Event
    September 3, 2009
    Report Date
    September 28, 2009
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    LXH
    PMA / PMN Number
    K050588
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SCREWDRIVERS VISUALLY INSPECTED, MET SPECIFICATIONS; FOUND NORMAL WEAR OF DEVICE. REVIEW OF DHR SHOWED NO ANOMALY WHICH COULD HAVE CONTRIBUTED TO INCIDENT. PROBLEM COULD NOT BE REPLICATED DURING EVALUATION OF COMPLAINT. DESIGN IMPROVEMENT PROJECTS HAD BEEN INITIATED PRIOR TO RECEIPT OF COMPLAINT. FIRST PROJECT INCLUDED MATERIAL CHANGE TO A STRONGER STAINLESS STEEL TYPE. SECOND INCLUDED A TIP GEOMETRY CHANGE WHICH WAS VERIFIED BY IN-HOUSE TESTING. BOTH CHANGES HAVE BEEN IMPLEMENTED.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, SURGEON (B)(6) USED TWO (2) SCREWDRIVERS FROM THE SAME TRAY. BOTH SCREWDRIVERS DID NOT HOLD SCREWS VERY WELL; SCREWS FELL OFF THE SCREWDRIVERS; DELAYING SURGERY SEVERAL SECONDS TO KEEP REATTACHING SCREW. NO ADVERSE EFFECT TO PATIENT. SECOND OF TWO REPORTS FOR THE SAME PATIENT/SURGERY BY THE SAME SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERTEVIEW ACPS SCREWDRIVER SPINAL INTERVERTEBRAL BODY FIXATION ORT LXH ATLAS SPINE, INC. 06411

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention