BEUDAMED
    FDA Adverse Event Other Summary report: N

    HYDROSET INJECTABLE HA BONE SUBSTITUTE CEMENT, 10C

    MDR report key: 1448990 · Received August 5, 2009

    Report

    Report Number
    8010177-2009-00101
    Event Type
    Other
    Date Received
    August 5, 2009
    Date of Event
    July 2, 2009
    Report Date
    July 6, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE IS NOT AVAILABLE TO STRYKER FOR EVALUATION.

    Description of Event or Problem · 1

    HYDROSET USED IN OFF LABEL SPINE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROSET INJECTABLE HA BONE SUBSTITUTE CEMENT, 10C IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other