BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 BASE UNIT, EXTENDED

    MDR report key: 6332875 · Received February 15, 2017

    Report

    Report Number
    3004608878-2017-00045
    Event Type
    Malfunction
    Date Received
    February 15, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 25, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORP (INTEGRA-OHIO)
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 3/15/2017. METHOD: DHR REVIEW TREND ANALYSIS FAILURE ANALYSIS DEVICE HISTORY RECORD REVIEWED FOR (B)(4) LOT 136867 A TOTAL OF (B)(4) WERE MANUFACTURED ON 08/06/2015 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. DEVICE HISTORY RECORD REVIEWED FOR (B)(4) LOT 131700 A TOTAL OF (B)(4) WERE MANUFACTURED ON 05/18/2015 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. DEVICE HISTORY RECORD REVIEWED FOR (B)(4) LOT 123336 A TOTAL OF (B)(4) WERE MANUFACTURED ON 01/26/15 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. DEVICE HISTORY RECORD REVIEWED FOR (B)(4) LOT 121045 A TOTAL OF (B)(4) WERE MANUFACTURED ON 09/04/2014 SHOW NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. A TWO YEAR LOOK BACK FOR THIS REPORTED FAILURE AND OR RELATED TO "STUD BREAKAGE" FOR THIS PRODUCT FAMILY SHOWS THAT 10 COMPLAINTS WERE RECEIVED INCLUDING THIS CASE. CUSTOMER DIDN'T RETURN AN ENTIRE A2079 UNIT, BUT RATHER THE SWIVEL ASSEMBLY A2400 AND THE SKULL CLAMP (THAT HAD THE PORTION OF THE BROKEN STUD IN IT). ¿ENGINEERING AND REPAIRS WERE ABLE TO CONFIRM THE CUSTOMER COMPLAINT¿ KNOB BROKE IN THREAD ROOT. THERE ARE NO VISIBLE INDICATIONS OF WHY THE PART FAILED. ALL APPLICABLE MACHINED SURFACES NEAR FRACTURE HAVE GOOD SURFACE FINISH, NO STEPS, OR SHARP CORNERS THAT CAN EXPLAIN THE COMPLAINT EVENT. CONCLUSION: ENGINEERING AND REPAIRS WERE ABLE TO VERIFY THE CUSTOMER COMPLAINT. (B)(4) BASE UNIT, (B)(4)STANDARD SWIVEL ASSEMBLY, STUD DETAIL (B)(4) BROKE IN THREAD. THE ROOT CAUSE CANNOT BE ATTRIBUTED AT THIS TIME.

    Description of Event or Problem · 1

    THE SCREW BROKE DURING THE POSTERIOR CERVICAL SPINAL FUSION. THE PATIENT WAS POSITIONED PRONE. AFTER THE DOCTOR WASHED HIS HANDS, THE SCREW NAPPED AND THE PATIENT'S HEAD DROPPED. THE SURGERY WAS DELAYED FOR 2 HOURS. THE BASE UNIT WAS REPLACED WITH ANOTHER METAL MAYFIELD DEVICE AND SURGERY CONTINUED. THERE WAS NO PATIENT INJURY REPORTED. THE FREQUENCY OF USE FOR THIS DEVICE WAS REPORTED AS 5-6 TIMES PER MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114539 MAYFIELD INFINITY XR2 BASE UNIT, EXTENDED MAYFIELD FWZ INTEGRA LIFESCIENCES CORP (INTEGRA-OHIO) 1526205

    Patients

    Seq Age Sex Outcome Treatment
    1