BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA LNG NL LFT 11X360MM 130

    MDR report key: 133072 · Received November 14, 1997

    Report

    Report Number
    9610622-1997-00127
    Event Type
    Malfunction
    Date Received
    November 14, 1997
    Date of Event
    March 17, 1997
    Report Date
    November 12, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF EVAL: EVAL RESULTS SUGGEST THAT THE NAIL BROKE DUE TO MATERIAL FATIGUE.

    Description of Event or Problem · 1

    OCTOBER 21, 1995, A GAMMA NAIL WAS IMPLANTED FOR A BROKEN FEMUR. 3-17-1997, REVISION SURGERY WAS REQUIRED BECAUSE OF THE FEMUR'S BREAKAGE ON PSEUDOARTHROSIS. THE BROKEN GAMMA NAIL WAS REPLACED BY A PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA LNG NL LFT 11X360MM 130 Implant IMPLANT HSB HOWMEDICA INC. NA K320844

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other GAMMA LAG SCREW, 12X90 MM