BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3016693 · Received March 19, 2013

    Report

    Report Number
    3004608878-2013-00050
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 19, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 MODIFIED SKULL CLAMP (LOT NUMBER AND EXPIRATION DATE UNKNOWN) WAS REPORTED TO HAVE SLIPPED WITH ROTATIONAL MOTION DURING A POSTERIOR FOSSA CRANIOTOMY. THE HEAD SLIPPED APPROXIMATELY 30 MINUTES AFTER STARTING THE CASE. THE PATIENT WAS POSITIONED PRONE AND SLIPPED OUT OF THE HEADREST. THE PATIENT INCURRED A SMALL DEEP SCALP LACERATION WHICH REQUIRED 2 STAPLES TO CLOSE THE WOUND. A REVISION WAS NOT REQUIRED. THE PATIENT OUTCOME WAS DESCRIBED AS NO PROBLEMS NOTED AND THE CHART NOTED THAT THE WOUND WITH STAPLES WAS HEALING WELL. CODMAN REUSABLE (CATALOG # 19-1031, LOT NUMBER UNKNOWN) ADULT SKULL PINS WERE USED DURING THE SURGERY. THE SKULL PINS ARE NOT AVAILABLE FOR EVALUATION. IT IS UNKNOWN WHETHER THE SURGERY WAS PERFORMED WITH A STEREOTAXY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114475 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR