BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD 200 RADIOLUCENT SKULL CLAMP

    MDR report key: 4152580 · Received September 8, 2014

    Report

    Report Number
    3004608878-2014-00177
    Event Type
    Injury
    Date Received
    September 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 8, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K953124
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE A2002 RADIOLUCENT SKULL CLAMP WAS REPORTED TO HAVE ROTATIONAL MOVEMENT WHEN LOCKED DURING A POSTERIOR CERVICAL LAMINECTOMY AND FUSION. THE NATURE OF THE MALFUNCTION WAS DESCRIBED AS "THE PIN WOULD NOT LOCK DOWN ON THE PATIENT'S SKULL." "THE SKULL PINS WERE FINE. THE 2 PIN OUT OF THE 3 PIN SET UP WOULD NOT LOCK IN." THE PT'S HEAD WOULD PIVOT EVEN THOUGH IT WAS LOCKED DOWN AND THE PT INCURRED A LACERATION. THE LACERATION DID NOT REQUIRE ANY SUTURING. THE LENGTH OF TIME IN USE BEFORE THE EVENT OCCURRED RIGHT AWAY. THE SURGERY WAS DELAYED FOR 1 HR. THE CLINICIAN REPORTED THAT THERE WAS NO HEAD OR NECK INJURY, HOWEVER, THE PT WAS PINNED 4 TIMES TO GET THE DEVICE TO LOCK IN. INTEGRA ADULT DISPOSABLE SKULL PINS (A1083) WERE USED. THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548928 MAYFIELD 200 RADIOLUCENT SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other