BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 3190106 · Received June 24, 2013

    Report

    Report Number
    3004608878-2013-00123
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    June 17, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE (MAYFIELD INFINITY SKULL CLAMP ALONG WITH THE A 1083 SKULL PINS) 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

    IT WAS REPORTED THAT THE ROCKER ARM SLIPPED, CAUSING A DEEP LACERATION. ADD'L INFO WAS REQUESTED AND THE FOLLOWING WAS PROVIDED ON (B)(6) 2013: THE MODEL NUMBER OF THE SKULL CLAMP WAS PRODUCT ID A1114 (INFINITY MAYFIELD HEAD CLAMP). THE (B)(6) FEMALE PT WAS TO UNDERGO A LAMINECTOMY FOR REMOVAL OF A SACRAL TUMOR. THE PT WAS ON A (B)(4) TABLE WITH CERVICAL MANAGEMENT SYSTEM AND THE INFINITY MAYFIELD HEAD CLAMP. THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE. INTEGRA DISPOSABLE ADULT SKULL PINS (A1083) WERE USED. LOT NUMBER OF THE SKULL PINS WAS NOT AVAILABLE. THE PT WAS IN A PRONE POSITION FOR SURGERY AND WAS NOT REPOSITIONED AT ANY TIME DURING THE SURGERY. IT WAS NOTED THAT THERE WAS BLEEDING COMING FROM THE PT'S HEAD AND AT THAT TIME, THE PT WAS TURNED SUPINE ONTO THE STRETCHER. THERE WAS NO NOTABLE SHIFTING OF THE HEADHOLDER NOTED BY THE NEUROSURGICAL RESIDENT. THE LENGTH OF TIME THE PRODUCT IN USE BEFORE THE EVENT OCCURRED WAS 15 MINUTES. THE PT SUSTAINED THE INJURY PRIOR TO THE START OF THE PROCEDURE. THE LACERATION WAS LEFT ANTERIOR, 5 MM IN LENGTH DISCOVERED AFTER PT HAD BEEN TURNED PRONE ONTO THE JACKSON TABLE. THE PT'S HEAD WAS SECURED INTO THE (B)(4) CERVICAL MANAGEMENT SYSTEM AND PT WAS BEING PADDED WITH FOAM IN PREPARATION FOR SURGERY. THE LACERATION WAS CLOSED WITH NON-INTEGRA VICRYL SUTURE AND THERE WAS NO VISIBLE OR REPORTED EFFECTS BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285330 MAYFIELD INFINITY SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention