BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TROCHANTERIC GRIP PLATE WITH 2

    MDR report key: 2143488 · Received June 2, 2011

    Report

    Report Number
    9616680-2011-00360
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 16, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    HRS
    PMA / PMN Number
    K070170
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON ASKED FOR MEDIUM 200MM GRIP PLATE WHICH IS SUPPOSED TO INCLUDE 2 CABLES. AFTER OPENING THE BOX AND THE STERILE PACKAGE, NO CABLES WERE INCLUDED. THE BOX ALSO SAYS W/2 CABLES. THE CASE WENT ON AND IT WAS NOT AN ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC GRIP PLATE WITH 2 IMPLANT HRS STRYKER ORTHOPAEDICS CORK NA G2990097

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other