BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRAMEDULLARY BONE PLUG

    MDR report key: 2861206 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02215
    Event Type
    Malfunction
    Date Received
    November 2, 2012
    Date of Event
    October 12, 2012
    Report Date
    October 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE BONE PLUG BROKE IN THE INTRODUCER. STILL WAITING FOR MORE DETAILS FROM HOSPITAL. ANOTHER IDENTICAL DEVICE WAS IMMEDIATELY AVAILABLE FOR USE AND CASE COMPLETED AS ORIGINALLY PLANNED. NO DELAY OR PATIENT IMPACT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRAMEDULLARY BONE PLUG IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other