BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD 2000 SKULL CLAMP

    MDR report key: 2102909 · Received May 4, 2011

    Report

    Report Number
    3004608878-2011-00063
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 5, 2011
    Report Date
    May 4, 2011
    Manufacturer
    INTEGRA, CINCINNATI
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE SURGEON NOTED A SHIFT IN THE MAYFIELD 2000 SKULL CLAMP DURING A POSTERIOR CERVICAL LAMINECTOMY. THE PHYSICIAN FELT THAT THE UNIT WAS LOOSE AT THE LOCKING MECHANISM AND WASN'T HOLDING PROPERLY. THE PT DID NOT INCUR AN INJURY WITH THIS EVENT. MAYFIELD SKULL PINS WERE USED DURING THE SURGERY. THERE WASN'T A STEREOTAXY DEVICE USED DURING THE PROCEDURE. SURGERY WAS NOT DELAYED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAYFIELD 2000 SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA, CINCINNATI 967

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR