BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERIES 7000 STANDARD TIBIA

    MDR report key: 2760259 · Received September 19, 2012

    Report

    Report Number
    2249697-2012-01596
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K910990
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING THE SURGERY, WHEN THEY OPENED THE OUTER TYVEK, THE INNER TYVEK WAS PEELED AWAY TOGETHER WITH THE OUTER TYVEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERIES 7000 STANDARD TIBIA IMPLANT JWH STRYKER ORTHOPAEDICS MAHWAH NA MLJTKE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other