BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR 6MM INSERTER

    MDR report key: 2941111 · Received January 16, 2013

    Report

    Report Number
    9617544-2013-90033
    Event Type
    Malfunction
    Date Received
    January 16, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    LXH
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE DISTAL TIP OF THE 6MM AIOG BROKE OFF INSIDE A 6X12X14X8 DEGREE ANCHOR C CAGE WHILE BEING IMPLANTED INTO THE CERVICAL DISC SPACE WITH THE ASSISTANCE OF A MALLET. DURING THE SAME CASE ON TWO SEPARATE OCCASIONS THE LOCKING RINGS FOR 3.5X12MM SELF DRILLING SCREWS HAD BROKEN OFF. THE ENTIRE RING BROKE OFF OF ONE OF THEM AND ANOTHER HAD A 2MM PORTION OF THE RING BREAK OFF. BOTH SCREWS WERE EXPLANTED AND REPLACED WITH RESCUE SCREWS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25192 ANCHOR 6MM INSERTER INSTRUMENT LXH STRYKER SPINE BORDEAUX NA 114010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR