BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APELO HEAD APPLICATOR TOOL

    MDR report key: 1558660 · Received November 20, 2009

    Report

    Report Number
    3003855635-2009-00008
    Event Type
    Malfunction
    Date Received
    November 20, 2009
    Date of Event
    October 19, 2009
    Report Date
    November 17, 2009
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS DETERMINED THAT THE RETRACTABLE TIP OF SUBJECT HEAD APPLICATION TOOL DID NOT PROPERLY RETRACT DURING SURGERY. THE LACK OF FULL RETRACTION INTO THE TOOL'S BODY PREVENTED THE MODULAR PEDICLE SCREW HEAD TO FULLY ATTACH TO THE PEDICLE SCREW HEADS. APPROPRIATE DEPTH HAD BEEN DETERMINED DURING AN UNRELATED INVESTIGATION INTO THE DEPTH OF THE SPRING RETRACTION CAVITY OF THE TOOL; RESULTING IN A DESIGN CHANGE STARTED ON (B)(4) 2009.

    Description of Event or Problem · 1

    DURING A SURGICAL PROCEDURE, DOCTOR DID NOT FEEL CONFIDENT WHILE SECURING THE IMPLANTS WITH THE TOOL. DOCTOR DECIDED TO REMOVE ALL THE IMPLANTS AND REPLACED WITH ANOTHER SYSTEM. THE SURGERY WAS DELAYED FOR APPROX 45 MINUTES AFTER DECIDING TO REPLACE THE SYSTEM. SURGERY COMPLETED WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APELO HEAD APPLICATOR TOOL HEAD APPLICATOR TOOL LXH ATLAS SPINE, INC. 00766

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention