BEUDAMED
    FDA Adverse Event Injury Summary report: N

    R90 SPACERS

    MDR report key: 1565112 · Received December 21, 2009

    Report

    Report Number
    1030489-2009-01221
    Event Type
    Injury
    Date Received
    December 21, 2009
    Date of Event
    November 30, 2009
    Report Date
    November 30, 2009
    Manufacturer
    SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2940521M, 510K # K033926 WAS CLEARED IN THE UNITED STATES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE DID NOT REVEAL ANY NON-CONFORMANCES TO SPECIFICATION OR DEVIATIONS IN PROCEDURE WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS UNDERGOING A PLIF CASE USING INTERBODY DEVICES. THE SURGEON FELT THAT ONE OF THE DEVICES WAS PLACED TOO FAR ANTERIORLY, BUT COULD NOT RETRIEVE THE DEVICE. AN X-RAY TAKEN INTRAOPERATIVELY SHOWED THAT THE DEVICE HAD SLIPPED FORWARD PAST THE ANTERIOR LONGITUDINAL LIGAMENT AND WAS UNABLE TO BE RETRIEVED. THE SURGEON IMPLANTED ANOTHER INTERBODY DEVICE INTO THE DISC SPACE UNEVENTFULLY. THE SURGEON REPORTED THAT NO ADVERSE EVENTS OCCURRED AND HE WILL CONTINUE TO MONITOR THE PATIENT POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R90 SPACERS CAGE MAX SOFAMOR DANEK DEGGENDORF GMBH NA PB24

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR