BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA NAIL LONG

    MDR report key: 204594 · Received December 30, 1998

    Report

    Report Number
    9610622-1998-00194
    Event Type
    Malfunction
    Date Received
    December 30, 1998
    Date of Event
    November 19, 1998
    Report Date
    December 29, 1998
    Manufacturer
    HOWMEDICA INC.
    Product Code
    JDS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NAIL IS BROKEN. PT CAME INTO HOS WITH 'INSTABIL' FEMUR. THERE WAS NO ADVERSE CONSEQUENCE FOR THE PT OR DELAY IN SURGERY OR ANESTHESIA TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA NAIL LONG Implant IMPLANT JDS HOWMEDICA INC. NA K363483

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other