BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY SKULL CLAMP

    MDR report key: 5169664 · Received October 22, 2015

    Report

    Report Number
    3004608878-2015-00277
    Event Type
    Malfunction
    Date Received
    October 22, 2015
    Date of Event
    September 10, 2015
    Report Date
    September 28, 2015
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K051440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/01/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: COMPLAINT WAS CONFIRMED VIA INSPECTION OF ITEM; IT WAS CONFIRMED THE RETURNED UNIT DID NOT MEET ALL SPECIFIC FUNCTIONAL TEST. THE RATCHET EXTENSION ARM WILL NOT GO THROUGH THE BASE FROM A NON-MAYFIELD PRODUCT WAS USED AND CAUSED DIMPLING ALONG THE SIDES OF THE RATCHET EXTENSION ARM CAUSING THE ARM TO NOT GO THROUGH THE BASE SMOOTHLY. THE LOCK HAS BOTH ROTATIONAL AND LATERAL MOVEMENT AND A RESIDUE BUILDUP IS PRESENT. THE LOCK WILL NEED NEW COMPONENTS ADDED TO REPLACE WORN INTERNAL PARTS; GENERAL MAINTENANCE AND CLEANING WAS REQUIRED. THIS DEVICE WAS MANUFACTURED ON SEPTEMBER 30TH, 2008 AND A REVIEW OF DHR'S CONTAINING LOT CODE 087 SHOWED THAT THE FOLLOWING LOTS BELOW PASSED THE REQUIRED INSPECTION POINTS WITHOUT VARIANCES. SERVICE HISTORY: DATE OF SERVICE: REASON FOR REPAIR: ROUTINE MAINTENANCE. NO MANUFACTURING OR DESIGN RELATED TREND HAS BEEN IDENTIFIED. CONCLUSION: IN SUMMARY WE WERE ABLE TO VERIFY THE END USERS REASON FOR RETURN. THE MOST LIKELY REASON COULD BE DUE TO THE DAMAGE CAUSED FROM A NON OEM PART USED IN CONJUNCTION WITH THE RETUNED DEVICE. PER THE IFU WITH RESPECT TO ¿NON-MAYFIELD BRANDED PRODUCTS USED WITH MAYFIELD PRODUCTS - WE CAUTION THAT WE HAVE ONLY VALIDATED MAYFIELD PRODUCTS USED IN CONJUNCTION WITH THE MAYFIELD PRODUCT LINE, AND AS A RESULT, CANNOT ADVISE YOU WHETHER SUPPLIERS¿ PRODUCTS WOULD WORK PROPERLY WITH THE MAYFIELD LINE OF PRODUCTS.¿ LASTLY PER THE IFU ¿ALWAYS USE A HORSESHOE HEADREST OR OTHER FORM OF PRIMARY PATIENT SUPPORT WHEN USING THE REDUCED LOAD TORQUE SCREW.¿

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PROBLEM, DIFFERENT PATIENTS). THIS IS REGARDS TO THE FIRST PATIENT ((B)(6) MALE). IT WAS REPORTED THAT WHEN WE USE THE 18 POUND TORQUE, IT WAS NOT HOLDING. THE PATIENT SLIPPED OUT OF THE PINS. ALSO, THE CLAMP WAS NOT SLIDING PROPERLY. IT WAS GETTING CAUGHT. THERE WAS NO PATIENT INJURY. THERE WAS A 30 MINUTE DELAY IN SURGERY. ADDITIONAL INFORMATION WAS REQUESTED AND ON 13 OCT 2015. THE SKULL CLAMP WAS NOT SLIDING CLOSE. IT KEPT GETTING STUCK ABOUT MID POINT (THE PATIENT WAS NOT IN THE CLAMP WHEN TRYING TO SLIDE IT TOGETHER). THE PATIENT WAS POSITIONED PRONE FOR A POSTERIOR FOSSA BRAIN TUMOR RESECTION. MAYFIELD DISPOSABLE CHILD SKULL PINS (PRODUCT ID A1084, LOT NUMBER 1142540) WERE USED. THE SKULL PINS WERE NOT AVAILABLE TO BE RETURNED FOR EVALUATION. WE DID NOT START THE SURGERY BECAUSE HE WAS SLIPPING OUT OF THE PINS. THE USER DID NOT GET FAR ENOUGH INTO THE CASE TO USE THE STEREOTACTIC EQUIPMENT. WHEN THE PATIENT WAS IN THE SKULL CLAMP, 18 POUNDS OF PRESSURE WAS USED BUT THE HEAD WAS NOT BEING HELD IN PLACE. IT KEPT MOVING BUT THE SURGEON DID NOT WANT TO USE MORE PRESSURE DUE TO THE CHILD'S SIZE. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS ABOUT 5 MINUTES; ENOUGH TIME TO PUT THE PATIENT IN PINS AND IT WAS NOTICED THAT HE WAS SLIPPING OUT. THE CLAMP WAS READJUSTED A COUPLE TIMES BUT THE PATIENT KEPT SLIPPING OUT SO A DIFFERENT SYSTEM WAS USED TO DO THE CASE. THERE WAS NO PATIENT ADVERSE CONSEQUENCE DUE TO THE 30 MINUTE DELAY. PATIENT OUTCOME WAS REPORTED AS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698589 MAYFIELD INFINITY SKULL CLAMP SKULL CLAMPS AND HEADREST SYSTEMS HBL INTEGRA LIFESCIENCES CORPORATION OH/USA 087

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR