BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSSE AND KEMPF NAIL

    MDR report key: 115497 · Received August 22, 1997

    Report

    Report Number
    9610622-1997-00074
    Event Type
    Malfunction
    Date Received
    August 22, 1997
    Date of Event
    July 1, 1994
    Report Date
    August 21, 1997
    Manufacturer
    HOWMEDICA INC.
    Product Code
    HSB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS FROM THE MANUFACTURER'S EVALUATION SUGGEST THAT THIS EVENT IS PT RELATED.

    Description of Event or Problem · 1

    A GROSSE AND KEMPF NAIL WAS IMPLANTED ON MAY 15, 1988. THE NAIL ALLEGEDLY CRACKED JULY 1, 1994, AND WAS REVISED JULY 13, 1994. NO ADVERSE CONSEQUENCE TO THE PATIENT OR SURGICAL DELAY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSSE AND KEMPF NAIL Implant IMPLANT HSB HOWMEDICA INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other