BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCOLADE STEM INSERTER

    MDR report key: 2090536 · Received April 19, 2011

    Report

    Report Number
    2249697-2011-00534
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 30, 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
    MA, US
    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

    IT WAS REPORTED THAT, "THE TIP OF THE INSERTER FRAYED OFF DURING IMPLANTATION. THE TIP WAS RECOVERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCOLADE STEM INSERTER INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA BPXS05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention