BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 3262036 · Received July 26, 2013

    Report

    Report Number
    3004608878-2013-00140
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 25, 2013
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT WAS INVOLVED IN A SLIP AND LACERATION. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2013, THE FOLLOWING WAS RECEIVED FROM THE CUSTOMER. ON (B)(6) 2013, A (B)(6) MALE PATIENT UNDERWENT A CRANIOTOMY FOR A TUMOR. THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE. THE PATIENT WAS INITIALLY POSITIONED SUPINE FOR THE SURGERY. THE SLIPPAGE OCCURRED WHILE ATTEMPTING TO REPOSITION THE PATIENT'S HEAD. THE SKULL CLAMP WITH ADULT PINS WAS APPLIED TO THE PATIENT'S HEAD WITH 60 POUNDS PRESSURE AND WAS LOCKED. WHILE THE PHYSICIAN WAS REPOSITIONING THE PATIENT'S HEAD, THE SLIPPAGE OCCURRED. THE CLAMP AND PINS WERE REMOVED. A TWO INCH LACERATION WAS NOTED ON THE LEFT SIDE OF THE HEAD. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS UNKNOWN. TREATMENT, PATIENT OUTCOME, AND INFORMATION ABOUT THE SKULL PINS WERE NOT PROVIDED. ON (B)(6) 2015, A MEDWATCH REPORT WAS RECEIVED WITH UF/IMPORTER REPORT NUMBER (B)(4). THE PHYSICIAN APPLIED THE MAYFIELD SKULL CLAMP WITH ADULT DISPOSABLE PINS TO THE PATIENT'S HEAD WITH 60 POUNDS (LBS) OF PRESSURE. THE HEAD REST WAS AFFIXED TO THE OPERATING ROOM BED AND LOCKED IN PLACE. WHILE REPOSITIONING THE PATIENT'S BODY, THE CLAMP SLIPPED. IT WAS NOTED THAT THERE WAS A 2 INCH LACERATION ON THE LEFT SIDE OF THE HEAD. THE CLAMP AND THE PINS WERE REMOVED AND ANOTHER MAYFIELD CLAMP AND ADULT DISPOSABLE PINS WERE APPLIED AND AFFIXED. THE LACERATION WAS CLEANED AND SUTURED. THE OPERATION PROCEEDED WITH NO SEQUELAE. DEVICES INVOLVED IN THE INCIDENT. MAYFIELD MODIFIED SKULL CLAMP, MODEL NUMBER A1059, SERIAL NUMBER (B)(4); MAYFIELD ADULT SKULL PINS A1072, LOT NUMBER 1130573.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351048 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 061

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention