BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD MODIFIED SKULL CLAMP

    MDR report key: 6379936 · Received March 6, 2017

    Report

    Report Number
    3004608878-2017-00064
    Event Type
    Malfunction
    Date Received
    March 6, 2017
    Report Date
    February 14, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 3/16/2017. METHOD: -DHR ANALYSIS, -TREND ANALYSIS, - FAILURE ANALYSIS. DEVICE HISTORY RECORD REVIEWED FOR THIS PRODUCT ID WORK ORDER AND SERIAL # 113801 / (B)(4) MANUFACTURED ON OCTOBER 09, 2014 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THIS DEVICE PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. POST MARKET INFORMATION WILL CONTINUE TO BE MONITORED. THE RETURNED UNIT LOCK HAS ROTATIONAL MOVEMENT WHEN UNIT IS NOT UNDER PRESSURE, THIS WOULD NOT HAVE CAUSED A SLIPPAGE. WHEN UNIT IS PROPERLY POSITIONED AND PUT UNDER PRESSURE UNIT WOULD NOT HAVE SLIPPED. UNIT WILL REQUIRE PM MAINTENANCE PREFORMED AT THIS TIME. SERVICE NOTES: UNIT RECEIVED WITH THE LOCK HAVING BOTH ROTATIONAL AND LATERAL MOVEMENT AND A RESIDUE BUILDUP IS PRESENT. UPON DISASSEMBLY REPAIR NOTED THE LOCK WILL NEED NEW COMPONENTS ADDED TO REPLACE WORN INTERNAL PARTS; UNIT NEEDS TO BE MACHINED TO HAVE HELI-COILS ADDED TO LARGE STARBURST THREADS; THE SET SCREW IN THE SWIVEL BASE WAS TIGHT; GENERAL MAINTENANCE AND CLEANING. CONCLUSION: IN SUMMARY, WE ARE UNABLE TO CONFIRM OR DUPLICATE THE END USERS EXPERIENCE. THE RETURNED UNIT PASSED ALL FUNCTIONAL TESTING REQUIREMENTS, HOWEVER GENERAL MAINTENANCE IS REQUIRED AS THIS DEVICE WAS MANUFACTURED IN 2014 WITH NO PRIOR SERVICE HISTORY. THE MAYFIELD PATIENT POSITIONING FOR SUCCESS CHART HAS BEEN PROVIDED AS A REFRESHER TOOL.

    Description of Event or Problem · 1

    SLIPPING OF THE DEVICE WAS REPORTED. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164055 MAYFIELD MODIFIED SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 147

    Patients

    Seq Age Sex Outcome Treatment
    1