BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAYFIELD HEAD HOLDER

    MDR report key: 4142557 · Received October 1, 2014

    Report

    Report Number
    3004608878-2014-00171
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    October 17, 2013
    Report Date
    August 22, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS 3 MAYFIELD POSITIONERS: 1 RETIRED POSITIONER (UNABLE TO DETERMINE WHAT TYPE OF MAYFIELD POSITIONER/PRODUCT ID SINCE IT HAS BEEN MONTHS THAT IT HAS BEEN RETIRED; THIS PRODUCT WILL NOT BE RETURNED SINCE IT'S RETIRED), THE 1 NEW POSITIONER = A1059 WITH LOT CODE 131, THE 1 SENT FOR INSPECTION/REPAIR = THE A1059 SENT AND ALREADY RECEIVED BY INTEGRA. THE CUSTOMER CAN SENT THE 1 NEW MAYFIELD POSITIONER/SKULL CLAMP ONCE THEY HAVE THE OTHER ONE A1049 BACK FROM REPAIR. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE CUSTOMER REQUESTED A PREVENTATIVE MAINTENANCE ON THE DEVICE. ON (B)(6) 2014, INTEGRA WAS ADVISED BY THE CUSTOMER THAT THERE WAS AN INCIDENT WITH THE DEVICE. NO OTHER INFORMATION PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014 AND (B)(6) 2014, THE FOLLOWING WAS PROVIDED BY THE CUSTOMER. THE CUSTOMER PROVIDED INCIDENTS REGARDING 3 PATIENTS IN WHICH THEIR MAYFIELD POSITIONERS (DOES NOT KNOW SPECIFICALLY WHICH POSITIONER WAS INVOLVED WITH WHICH PATIENT) HAVE BEEN INVOLVED. THE USER FACILITY HAS 3 MAYFIELD POSITIONERS (1 POSITIONER RETIRED (UNKNOWN PRODUCT ID), 1 NEW AND IN EXCELLENT CONDITION (UNKNOWN PRODUCT ID); 1 SENT FOR INSPECTION/REPAIR TO INTEGRA (A1059 SKULL CLAMP)). SURGERY WAS PERFORMED BY THE SAME SEASONED SURGEON FOR ALL 3 PATIENT/S INCIDENTS. PHYSICIAN RE-EDUCATION WAS PROVIDED REGARDING UTILIZATION OF DEVICE. THE CUSTOMER CONFIRMED THAT NONE OF THE 3 INCIDENTS WERE EVER REPORTED TO INTEGRA BEFORE; ONLY INTERNALLY WITHIN THEIR OWN FACILITY. THIS REPORT IS IN REGARDS TO PATIENT 1. ON (B)(6) 2013, A MALE PATIENT UNDERWENT A POSTERIOR CERVICAL LAMINECTOMY WITH REINSTRUMENTATION. THE PATIENT WAS POSITIONED PRONE. NO STEREOTAXY DEVICE WAS USED. IT WAS REPORTED THAT THE PINS SLIPPED AND THERE WAS A 1/2 INCH SKIN LACERATION. STAPLE AND BACITRACIN OINTMENT WERE APPLIED. PATIENT OUTCOME WAS REPORTED AS STABLE. ADDITIONAL INFORMATION/CLARIFICATION WAS RECEIVED FROM CUSTOMER ON (B)(6) 2014: CUSTOMER WAS NOT SURE WHICH ONE OF THEIR 3 POSITIONERS WAS USED ON THIS PATIENT. THE CUSTOMER STATED: THE 1 RETIRED POSITIONER (UNABLE TO DETERMINE WHAT TYPE OF MAYFIELD POSITIONER/PRODUCT ID SINCE IT HAS BEEN MONTHS THAT IT HAS BEEN RETIRED), THE 1 NEW POSITIONER = A 1059 WITH LOT CODE 131, THE 1 SENT FOR INSPECTION/REPAIR = THE A1059 SENT AND RECEIVED BY INTEGRA. THE CUSTOMER CAN SEND THE 1 NEW MAYFIELD POSITIONER/SKULL CLAMP ONCE THEY HAVE THE OTHER ONE A1059 BACK FROM REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611484 MAYFIELD HEAD HOLDER SKULLCLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R