BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIUS 5.5 X 40 RAD ROD

    MDR report key: 1840889 · Received September 10, 2010

    Report

    Report Number
    9617544-2010-00370
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 25, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    NKB
    PMA / PMN Number
    K062270
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "THE PATIENT FELT A "POP." UPON XRAY EVAL, THE ROD HAD MIGRATED CEPHLAD AND SLIPPED OUT OF THE MOST CAUDAL SCREW. THE PATIENTS ORIGINAL SURGERY WAS (B)(6)2010, HE FELT A POP ON (B)(6)2010. THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM, NEW CAPS WERE INSERTED ON THE AFFECTED SIDE AND THE PATIENT WAS SENT HOME NEXT DAY. THE CAPS WERE LOCKED AND VISUALLY CONFIRMED BY ALL IN THE ROOM. THE PATIENT FELT ANOTHER "POP" THE FOLLOWING DAY. THE SAME THING HAPPENED, THE ROD HAD SLIPPED CEPHLAD AGAIN. THE PT WAS BROUGHT BACK A SECOND TIME. THE ENTIRE CONSTRUCT WAS REPLACED THIS TIME. L4 AND L5 SCREWS AS WELL AS CAPS AND RODS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIUS 5.5 X 40 RAD ROD IMPLANT NKB STRYKER SPINE BORDEAUX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR