BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSP SHOULDER INSTRUMENT

    MDR report key: 2062114 · Received March 17, 2011

    Report

    Report Number
    1644408-2011-00146
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 2011
    Manufacturer
    ENCOR MEDICAL, L.P.
    Product Code
    HTO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INSTRUMENT FAILURE - THE GLENOID REAMER LOCKED UP IN THE TAP (SIZE 6.5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSP SHOULDER INSTRUMENT GLENOID SMALL SHOULDER REAMER HTO ENCOR MEDICAL, L.P. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR 804-03-008, LOT N/A