BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 SKULL CLAMP

    MDR report key: 3181992 · Received June 17, 2013

    Report

    Report Number
    3004608878-2013-00118
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 17, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SLIPPED WHILE IN A MAYFIELD INFINITY XR2 SKULL CLAMP DURING A RIGHT CRANIOTOMY. THE PATIENT WAS NOT REPOSITIONED PRIOR TO THE SLIPPAGE, SHE WAS ONLY POSITIONED ONCE. THE PATIENT WAS NOT INJURED AS A RESULT OF THIS EVENT. THE SURGERY WAS DELAYED APPROXIMATELY 20 MINUTES, WHILE THE DRAPES WERE TAKEN DOWN, RE-PINNED THE PATIENT AND THEN PREPPED AGAIN AND DRAPED. THE PATIENT DID WELL AND WAS DISCHARGED HOME ON (B)(6) 2013 WITHOUT INCIDENT. MAYFIELD ADULT, DISPOSABLE SKULL PINS (INTEGRA REF (B)(4)). UNKNOWN LOT NUMBER. THERE WAS NO NEURONAVIGATION USED DURING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274256 MAYFIELD INFINITY XR2 SKULL CLAMP MAYFIELD HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR