BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANCHOR C 7MM INSERTER

    MDR report key: 2852197 · Received November 12, 2012

    Report

    Report Number
    9617544-2012-00496
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    ODP
    PMA / PMN Number
    K102606
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION 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

    THE SCRUB TECH WAS USING THE 7 X 12 X 14 X 4 DEGREE ANCHOR C CAGE WITH THE 7 MM ANCHOR C INSERTER. WHILE CONNECTING THE CAGE TO THE INSERTER, THE CAGE BECAME CROSS THREADED. THE SECOND SCRUB TECH TOOK THE INSERTER AND CAGE FROM THE FIRST SCRUB TECH AND ATTEMPTED TO TIGHTEN THE CAGE ON THE INSERTER. UPON DOING SO, THE INSERTER TIP BROKE OFF IN THE CAGE. I INFORMED DR (B)(6) AND ASKED IF HE COULD USE AN 8 X 12 X 14 X 4 DEGREE ANCHOR C CAGE. HE INFORMED ME THAT SIZE WOULD WORK AND THAT IS WHAT HE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANCHOR C 7MM INSERTER INSTRUMENT ODP STRYKER SPINE BORDEAUX NA 114011

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK (B)(4) ANCHOR C 7X12X14X4 DEG. CERVICAL STD ALON