BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OIC PEEK SIZE 10 MM - 4DEG

    MDR report key: 1931735 · Received November 22, 2010

    Report

    Report Number
    9617544-2010-00466
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 8, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    MAX
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ENGINEERING EVAL.

    Description of Event or Problem · 1

    DURING SURGERY, THE OIC PEEK CAGE WAS FRACTURED WHILE BEING IMPACTED INTO THE PT. (THE SURGEON TRIED TO PLACE THE CAGE VERY TIGHT, THUS THE RETRACTION MIGHT HAVE BEEN NOT ADEQUATE.) THE MAIN BROKEN PIECE WAS RETRIEVED; HOWEVER, IT IS NOT POSSIBLE TO CONFIRM WHETHER A TINY BROKEN PIECE IS REMAINED OR NOT. AS A RESULT, THE CAGE THAT IS ONE SIZE SMALLER WAS PLACED. THE PRODUCT IS AVAILABLE FOR EVAL; HOWEVER, IT NEEDS TO BE RETURNED TO THE CUSTOMER. NO X-RAY IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OIC PEEK SIZE 10 MM - 4DEG IMPLANT MAX STRYKER SPINE BORDEAUX NA 58275

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK