BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIZUHO CARBON FIBER HEAD PIN

    MDR report key: 3213243 · Received June 26, 2013

    Report

    Report Number
    1223656-2013-00001
    Event Type
    Other
    Date Received
    June 26, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MIZUHO AMERICA, INC.
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HEADPIN TIP BROKE DURING PT FIXATION PROCESS. PIN TIP CAME OUT OF THE SHAFT OF THE PIN. PINS ARE USED IN CONJUNCTION WITH THE BRAIN RETRACTION SYSTEM. PT HAD A GASH AS A RESULT OF THIS BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289882 MIZUHO CARBON FIBER HEAD PIN SKULL PIN HBL MIZUHO AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention