BEUDAMED
    FDA Adverse Event Other Summary report: N

    BONESOURCE CLASSIC, 25 GRAM

    MDR report key: 2061024 · Received April 13, 2011

    Report

    Report Number
    8010177-2011-00114
    Event Type
    Other
    Date Received
    April 13, 2011
    Date of Event
    March 20, 2011
    Report Date
    March 21, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT AVAILABLE FOR RETURN. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    BONESOURCE WAS IMPLANTED ON SUNDAY AND THE HOSP CALLED TO TELL OUR REP THAT THE EXP DATE WAS FROM 2008. THE HOSP DID NOT REPORT ANY ISSUE WITH THE SURGERY OR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONESOURCE CLASSIC, 25 GRAM IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA BS07015A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other