BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD HEAD HOLDER

    MDR report key: 5279060 · Received December 9, 2015

    Report

    Report Number
    3004608878-2015-00303
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    October 12, 2015
    Report Date
    November 18, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(6) 2016. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE IN QUESTION WAS NOT SENT IN FOR INSPECTION NOR WAS THE LOT# PROVIDED. THE LOT CODE COULD BE 107 AS SUCH: THIS DEVICE WAS MANUFACTURED ON (B)(6) 2009 AND A REVIEW OF THE WORK ORDER 082661 SHOWED THAT THIS LOT PASSED THE REQUIRED INSPECTION POINTS WITHOUT REWORKS, VARIANCES OR MRRS. THERE IS NO SERVICE HISTORY FOR THIS DEVICE. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. THE DEVICE WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE PATIENT WAS IN THE PRONE POSITION ON A JACKSON TABLE WITH HER HEAD IN MAYFIELD PINS AND HEADREST. DURING THE PROCEDURE, ONE OF THE HINGES (THAT WERE TIGHTENED ONCE THE HEADREST WAS IN PROPER POSITION) SLIPPED AND THE PATIENT'S HEAD FELL FORWARD, WITH HER NOSE COMING IN CONTACT WITH THE METAL OF THE HEADREST/MAYFIELD CONTRAPTION. THERE WAS NO PATIENT INJURY REPORTED. IT WAS NOTICED IMMEDIATELY BY THE PHYSICIANS. SURGERY WAS HALTED, DRAPES WERE LIFTED, AND THE PATIENT WAS RE-POSITIONED. THE MAYFIELD HAD BEEN TIGHTENED TO THE PROPER LEVEL. IT WAS UNKNOWN WHY IT SLIPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812229 MAYFIELD HEAD HOLDER SKULLCLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1