BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G/K FEM NAIL LEFT 10MMX38CM

    MDR report key: 217600 · Received April 1, 1999

    Report

    Report Number
    9610622-1999-00022
    Event Type
    Malfunction
    Date Received
    April 1, 1999
    Report Date
    April 1, 1999
    Manufacturer
    HOWMEDICA INC.
    Product Code
    JDS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT NAIL BROKE AT THE PROXIMAL OF THE DISTAL BORE-HOLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G/K FEM NAIL LEFT 10MMX38CM Implant IMPLANT JDS HOWMEDICA INC. NA K326880

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other