BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THREADED LOCKING DRIVER

    MDR report key: 3223914 · Received July 3, 2013

    Report

    Report Number
    3009049161-2013-00001
    Event Type
    Malfunction
    Date Received
    July 3, 2013
    Date of Event
    June 11, 2013
    Report Date
    July 3, 2013
    Manufacturer
    ALTUS SPINE
    Product Code
    HXX
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR EVAL. MFG DEVICE HISTORY RECORDS (DHR) WERE REVIEWED AND IT WAS CONFIRMED THAT MATERIAL, HEAT TREAT, AND PROCESSING WERE ACCURATE. ALL RECORDS INDICATE THE PRODUCT WAS MFG TO SPECIFICATIONS. HARDNESS TESTING WAS PERFORMED AND TEST RESULTS WERE CONSISTENT WITH THE MATERIAL SPECIFIED. OPTICAL INSPECTION WAS PERFORMED AND NO ANOMALIES FOUND. BASED ON THE RESULT OF INVESTIGATION IT IS CONCLUDED THAT THE CAUSE OF THE FAILURE IS NOT DUE TO MFG OR PRODUCT NON-CONFORMANCES. IT WAS DETERMINED THAT THE USER DID NOT HAVE THE DEVICE PROPERLY PREPARED FOR USE FOLLOWING THE MFR'S INSTRUCTIONS. THE SCREWDRIVER WAS NOT FULLY ENGAGED WITH THE IMPLANT AND THE IMPLANT BECAME LOOSE FROM THE SCREWDRIVER PRIOR TO TIP FRACTURE.

    Description of Event or Problem · 1

    A THREADED LOCKING DRIVER (905-1015; LOT AP30612) BROKE DURING A 1-LEVEL LUMBAR CASE ON (B)(6) 2013. SPECIFICALLY, THE SCREWDRIVER TIP BROKE DURING SCREW PLACEMENT. THE FLUOROSCOPY CONFIRMED THE SEGMENT WAS NOT OUTSIDE THE SCREW BODY. THE PROCEDURE CONTINUED WITHOUT INCIDENT WITH THE INTRODUCTION OF THE LONGITUDINAL ROD AND LOCKING CAP, THE FRACTURED SEGMENT WAS CONTAINED AND ISOLATED FROM CONTACT WITH BODY TISSUE. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304657 THREADED LOCKING DRIVER LOCKING SCREWDRIVER HXX ALTUS SPINE AP30512

    Patients

    Seq Age Sex Outcome Treatment
    1