BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APELO SCREWDRIVER

    MDR report key: 1589734 · Received January 27, 2010

    Report

    Report Number
    3003855635-2010-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 29, 2009
    Report Date
    January 22, 2010
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    HXX
    PMA / PMN Number
    K072426
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD(S), RESULT(S), AND CONCLUSION(S) WILL BE PROVIDED IN A SUPPLEMENTAL REPORT FOLLOWING COMPLETION OF EVALUATION.

    Description of Event or Problem · 1

    DURING REVISION SURGERY TO REPLACE HARDWARE ORIGINALLY IMPLANTED IN PATIENT IN 1990, THE DOCTOR WAS INSERTING A SCREW INTO VERY HARD BONE. THE SCREWDRIVER TIP BROKE BEFORE FULLY SEATING SCREW. A SECOND SCREWDRIVER WAS USED IN AN ATTEMPT TO REMOVE THE SAME SCREW WHICH COULD NOT BE DRIVEN INTO THE HARD BONE. THE SECOND SCREWDRIVER TIP BROKE. OTHER TOOLS WERE USED TO REMOVE THE SCREW AND SURGERY CONTINUED WITH NO FURTHER COMPLICATIONS TO THE PATIENT. SURGERY DELAYED APPROXIMATELY ONE AND A HALF HOURS. THIS IS THE FIRST OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APELO SCREWDRIVER SCREWDRIVER HXX ATLAS SPINE, INC. 00800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention