BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROSCOPIC RHOTON HOOK #10

    MDR report key: 2463195 · Received February 14, 2012

    Report

    Report Number
    2463195
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    February 7, 2012
    Report Date
    February 14, 2012
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    TIP OF MICROSCOPIC RHOTON HOOK BROKE OFF DURING NEUROSURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROSCOPIC RHOTON HOOK #10 HOOK GDG CODMAN & SHURTLEFF, INC. RHOTON #10 *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR