BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUGITA HEAD PIN

    MDR report key: 2436000 · Received July 28, 2011

    Report

    Report Number
    1223656-2011-00002
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    April 9, 2011
    Report Date
    April 12, 2011
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUGITA RETRACTORS PINS BENT AND CRACKED WHILE PLACING PATIENT IN THE HEAD FRAME AT THE START OF SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUGITA HEAD PIN SUGITA RETRACTOR PIN HBL MIZUHO AMERICA, INC. 07-985-08

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention