BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 2870051 · Received December 10, 2012

    Report

    Report Number
    3004608878-2012-00230
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K051440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    AN A1114 INFINITY MAYFIELD SKULL CLAMP WAS REPORTED TO HAVE BEEN INVOLVED IN A SLIPPAGE. THE INCIDENT WAS DESCRIBED AS FOLLOWS; "THE PATIENT MOVED DURING SURGERY IN FLEXION/EXTENSION ROTATIONAL MANNER ACCORDING TO PERSONAL REPORTS FROM NEURO COORDINATOR." ADDITIONAL INFORMATION RECEIVED FROM THE NEUROCOORDINATOR ON (B)(6) 2012: THE PATIENT WAS A CHILD WHO WAS PREPARED FOR A CRANIO-CERVICAL DECOMPRESSION FOR CHIARI MALFORMATION. THE CHILD WAS NOT REPOSITIONED AT ANY TIME DURING THE PROCEDURE WHEN SUDDENLY THE CHILDS' HEAD MOVED. NO INJURY WAS INVOLVED. THE NEUROSURGEON HAS BEEN DOING PROCEDURES INVOLVING THE MAYFIELD SKULL CLAMPS FOR YEARS AND IT WAS FELT THAT THE SLIPPAGE WAS DUE TO THE SKULL CLAMP NOT USER ERROR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1