BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR SCREWDRIVER, APELO

    MDR report key: 1616050 · Received February 19, 2010

    Report

    Report Number
    3003855635-2010-00003
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 18, 2010
    Report Date
    February 16, 2010
    Manufacturer
    ATLAS SPINE INC.
    Product Code
    HXX
    Product Problem
    Yes
    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 A SURGICAL PROCEDURE, THE CLOVER DRIVE OF THE TOOL BROKE UPON SCREW INSERTION. THE SCREW WAS FULLY INSERTED WHEN THE TOOL BROKE. THE CLOVER TIP OF THE TOOL BROKE INSIDE THE SCREW. DR WAS NOT ABLE TO REMOVE THE CLOVER TIP FROM THE SCREW. SURGERY CONTINUED WITH NO COMPLICATIONS TO THE PATIENT, AND WITH NO DELAY OF SURGERY. CONSEQUENTLY TIP WAS IMPLANTED INTO THE PATIENT. IT SHOULD BE NOTED THAT THE TIP IS FULLY INCAPSULATED BY THE PEDICLE SCREW SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention