BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD HEAD HOLDER

    MDR report key: 6010799 · Received October 7, 2016

    Report

    Report Number
    3004608878-2016-00275
    Event Type
    Malfunction
    Date Received
    October 7, 2016
    Date of Event
    September 29, 2016
    Report Date
    September 29, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PREAMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS EXPECTED TO BE RETURNED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 11/14/2016. . THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE IN QUESTION WAS NOT RELEASED FOR INSPECTION NOR WAS THE LOT# PROVIDED. THE LOT # COULD BE: LOT# MANUFACTURING DATE. 001 MARCH 31, 2000. 989 DECEMBER 31, 1989. 907 CODMAN MANUFACTURED IN 1994 AND UPGRADED IN 2000. A TWO YEAR LOOKBACK IN TRACKWISE FOR THIS REPORTED FAILURE AND OR RELATED TO "LOCKING SCREW SLID AND UNIT LOST PRESSURE/PRESSURE APPLIED HAD FALLEN " FOR THIS PRODUCT ID SHOWS THAT 5 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE, SEE BELOW. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: IN SUMMARY - THE DEVICE WAS NOT RELEASED FOR EVALUATION THEREFORE THE ROOT CAUSE TO THE END USERS EXPERIENCE COULD NOT BE DETERMINED. THIS COMPLAINT WILL BE REOPENED SHOULD WE RECEIVE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEONS FELT LIKE THE LOCKING SCREW MAY HAVE SLID DURING THE CASE AND THE UNIT MAY HAVE LOST PRESSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663739 MAYFIELD HEAD HOLDER SKULLCLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1