BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 1071375 · Received July 7, 2008

    Report

    Report Number
    3004608878-2008-00040
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 7, 2008
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE CLAMP ON THE ROCKER ARM OF THE DEVICE UNLOCKED AND CAUSED A GASH IN THE PT'S SKULL. ADDITIONAL INFO WAS RECEIVED IN 2008: WAS ADVISED THAT WHILE A CRANIOTOMY WAS BEING PERFORMED SIX DAYS PRIOR, THE DEVICE SLIPPED, AND THE PT SUSTAINED A LACERATION WHICH REQUIRED 3-4 STAPLES. IT WAS A SUPERFICIAL LACERATION. THERE WERE NO POST-OPERATIVE COMPLICATIONS TO THE REPORTER'S KNOWLEDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD INFINITY SKULL CLAMP NONE HBL INTEGRA LIFESCIENCES CORPORATION 084

    Patients

    Seq Age Sex Outcome Treatment
    1