BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSTEONICS C-TAPER HEAD

    MDR report key: 368420 · Received December 19, 2001

    Report

    Report Number
    2243265-2001-00140
    Event Type
    Malfunction
    Date Received
    December 19, 2001
    Report Date
    November 28, 2001
    Manufacturer
    HOWMEDICA OSTEONICS
    Product Code
    KWY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, A 06-2800 HEAD THAT DID NOT FIT ONTO AN EON STEM. THERE WAS NO ADVERSE CONSEQUENCES FOR THE PATIENT OR EXTENSION OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57459 OSTEONICS C-TAPER HEAD IMPLANT KWY HOWMEDICA OSTEONICS NA 68707503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other