BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFAIR HEAD HOLDER

    MDR report key: 4152482 · Received October 6, 2014

    Report

    Report Number
    3004608878-2014-00173
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    December 20, 2013
    Report Date
    September 11, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    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 ITS RETIRED), THE 1 NEW POSITIONER = 1059 WITH LOT 131, THE 1 SET SOR 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 A1059 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 PROVIDED INCIDENTS REGARDING 3 PATIENTS IN WHICH THEIR MAYFIELD POSITIONERS (DOSE 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 FOR INSPECTION/REPAIR TO INTEGRA (A1059 SKULL CLAMP)). SURGERY WERE PERFORMED BY THE SAME SEASONED SURGEON FOR ALL 3 PATIENTS/INCIDENTS. PHYSICIAN RE-EDUCATION 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 3. ON (B)(6) 2013, A MALE PATIENT UNDERWENT A POSTERIOR CERVICAL FUSION. THE PATIENT WAS POSITIONED PRONE. NO STEREOTAXY DEVICE WAS USED. IT WAS REPORTED THAT THE SURGEON WAS AT THE HEAD OF BED, THE PATIENT WAS IN PINS AND WAS TURNED PRONE ONTO GEL ROLLS. DURING POSITIONING, THE PATIENT'S HEAD CAME OUT OF THE PINS. THERE WAS NO PATIENT INJURY NOTED. NO MEDICAL INTERVENTION NECESSARY. PATIENT OUTCOME WAS REPORTED AS STABLE. ADDITIONAL INFORMATION/CLARIFICATION WAS RECEIVED FROM CUSTOMER ON 12SEP2014, 14SEP2014, 17SEP2014 AND 22SEP2014: 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 = A1059 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
    622185 MAYFAIR HEAD HOLDER SKULLCLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1