BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCORPIO TIBIAL TEMPLATE

    MDR report key: 2182170 · Received June 23, 2011

    Report

    Report Number
    2249697-2011-00953
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PER RAISED WITH MINIMAL INFORMATION: THE SALES REP (B)(6) REPORTED THAT THE PRODUCT WAS BROKEN. NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCORPIO TIBIAL TEMPLATE INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other