BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3190112 · Received June 24, 2013

    Report

    Report Number
    3004608878-2013-00120
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 24, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE A1059 SKULL CLAMP SLIPPED WHILE ON THE PT'S HEAD. THE PT DID SUFFER A "SCRAPE" WHERE THE SKULL PINS SLID ON THE PT'S HEAD. ADD'L INFO WAS REQUESTED AND THE FOLLOWING INFO WAS PROVIDED ON (B)(6) 2013: THE PT IS A (B)(6) FEMALE PT. TYPE OF SURGERY WAS A POSTERIOR CERVICAL LAMINECTOMY. THE PT WAS FLIPPED TO PRONE POSITON AT THE BEGINNING OF THE CASE. THEY JUST WANTED TO REPOSITION THE BASE UNIT SO A RESIDENT RELEASED THE BASE UNIT WHILE THE DOCTOR HELD THE HEAD IN THE CLAMP. AT THAT POINT, THE HEAD SLIPPED. IT MADE A "MECHANICAL SOUND" WHEN IT SLIPPED BUT DID NOT SOUND LIKE THE TYPICAL RATCHETING OR SKIN TEARING. THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE. INTEGRA DISPOSABLE ADULT SKULL PINS (A1083) WERE USED. THE SKULL PINS ARE NOT AVAILABLE TO BE RETURNED. THE LENGTH OF TIME THE SKULL CLAMP WAS IN USE BEFORE THE EVENT OCCURRED WAS 15 MINUTES. THE PT INJURY WAS REPORTED AS 6CM LONG, A COUPLE OF INCHES ABOVE THE LEFT EAR. TEN STITCHES, MAYBE A FEW MORE, WERE NEEDED. THE SURGERY WAS NOT PERFORMED THAT DAY. THE PT CAME BACK TWO DAYS LATER AND SURGERY WENT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285331 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention