BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD INFINITY SKULL CLAMP

    MDR report key: 1914352 · Received November 17, 2010

    Report

    Report Number
    3004608878-2010-00129
    Event Type
    Other
    Date Received
    November 17, 2010
    Date of Event
    October 22, 2010
    Report Date
    November 17, 2010
    Manufacturer
    INTEGRA-OHIO, INC.
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOUBLE SIDE OF THE ROCKER ARMS FELL OUT TWO TIMES BEFORE THE SURGICAL RESIDENT FINALLY PINNED THE HEAD OF THE PT TO THE SKULL CLAMP. MAYFIELD DISPOSABLE ADULT SKULL PINS (B)(4) WERE USED. THE PT WAS THEN FLIPPED ONTO THEIR STOMACH AND ATTACHED TO THE OPERATING ROOM (OR) BED. AT THAT TIME, THE RESIDENT NOTICED THAT THE SKULL CLAMP HAD SLIPPED. THERE WERE LACERATIONS ON THE PT'S LEFT TEMPORAL SKIN. THE SKULL CLAMP WAS REMOVED. SUTURES WERE USED TO STOP THE BLEEDING ON THE SKIN. A DIFFERENT SKULL CLAMP WAS USED AND THE PT WAS RE-PINNED AND THE PROCEDURE CONTINUED. ADDITIONAL CLINICAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD INFINITY SKULL CLAMP NA HBL INTEGRA-OHIO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1