BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 2891044 · Received December 20, 2012

    Report

    Report Number
    3004608878-2012-00236
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 20, 2012
    Manufacturer
    INTEGRA BURLINGTON, MAN, INC.
    Product Code
    HBL
    Adverse Event
    Yes
    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

    A MAYFIELD ULTRA BASE UNIT WAS REPORTED TO HAVE SLIPPED DURING A CRANIOTOMY. THE EVENT WAS DESCRIBED AS FOLLOWS; THE SURGERY WAS COMPLETED WITHOUT REPOSITIONING THE PT HOWEVER, AFTER THE SURGERY THE NEUROSURGEON COMMENTED THAT HE FELT THE ULTRA BASE UNIT SLIP. IT WAS NOTED THAT THE PT HAD A CLOSED "DIVOT" IN HER UPPER LIP BUT, IT IS NOT KNOWN WHETHER SHE HAD IT PRIOR TO THE SURGERY. THE BURR HOLE IN HER HEAD HOWEVER, WAS NOTED TO BE LARGER THAN USUAL. THERE WERE NO TREATMENTS REQUIRED. NO STEREOTACTIC DEVICE WAS USED DURING THIS PROCEDURE. CODMAN SKULL PINS WERE USED WITH THE MAYFIELD ULTRA BASE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS HBL INTEGRA BURLINGTON, MAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR