BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAYFIELD

    MDR report key: 556855 · Received August 24, 2004

    Report

    Report Number
    1525725-2004-00012
    Event Type
    Other
    Date Received
    August 24, 2004
    Date of Event
    April 1, 2004
    Report Date
    April 13, 2004
    Manufacturer
    SCHAERER MAYFIELD USA, INC.
    Product Code
    HBF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING INFO WAS SUBMITTED TO SCHAERER MAYFIELD USA, INC. BY MEDICAL CENTER: THE PT WAS IN THE PRONE POSITION. THE MD STATED HE WAS HOLDING ONTO SKULL CLAMP AND FLEXING THE PT'S NECK WHEN THE PIN SLIPPED. THE INJURY WAS 8 CM IN LENGTH AND LOCATED AT THE LEFT PARIETAL. THE LACERATION REQUIRED CLOSING WITH SKIN STAPLES. THERE WERE NOT POST OPERATIVE COMPLICATIONS REPORTED AS A RESULT OF THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD SKULL CLAMP HBF SCHAERER MAYFIELD USA, INC. 4-A-1059 984

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other