BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM CURVED QUICK-CONNECT

    MDR report key: 1973842 · Received December 28, 2010

    Report

    Report Number
    2249697-2010-01898
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFO BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "HANDLE CRACKED ON THE CUP IMPACTION HANDLED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUSTOM CURVED QUICK-CONNECT INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA F3N6883

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention