BEUDAMED
    FDA Adverse Event Other Summary report: N

    R90 SPACERS

    MDR report key: 1530981 · Received November 6, 2009

    Report

    Report Number
    1030489-2009-01046
    Event Type
    Other
    Date Received
    November 6, 2009
    Date of Event
    October 8, 2009
    Report Date
    October 8, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC
    Product Code
    MAX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 2940532L, 510K # K033926 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PLIF AT L2/3 TO IMPLANT TWO INTERBODY DEVICES AND POSTERIOR FIXATION CONCOMITANTLY. THE FIRST CAGE WAS IMPLANTED WITHOUT ANY COMPLICATIONS. THE SECOND CAGE WAS IMPLANTED TOO FAR ANTERIORLY. THE CAGE COULD NOT BE RETRIEVED. THE PT HAS BEEN OBSERVED FOR A PERIOD OF TIME. NO PT COMPLICATIONS WERE REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 R90 SPACERS CAGE MAX WARSAW ORTHOPEDIC INC NA 0003757W

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other