BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 BASE UNIT

    MDR report key: 6186221 · Received December 19, 2016

    Report

    Report Number
    3004608878-2016-00347
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Report Date
    November 29, 2016
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FWZ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 17 JAN 2017: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A DHR REVIEW CANNOT BE PERFORMED AT THIS TIME AS THE LOT NUMBER WAS NOT PROVIDED NOR WAS THE PRODUCT SENT IN FOR INSPECTION. THIS REVIEW WILL TAKE PLACE ONCE EITHER OR HAS BEEN PROVIDED. A TWO YEAR LOOKBACK IN (B)(6) FOR THIS REPORTED FAILURE AND OR RELATED TO "CRACKED OR BROKE" FOR THIS PRODUCT FAMILY SHOWS THAT 7 COMPLAINTS WERE RECEIVED INCLUDING THE 3 CASES REPORTED BY THIS CUSTOMER ON THE SAME DATE. NO NEW DESIGN OR MANUFACTURING TRENDS HAVE BEEN IDENTIFIED. THIS ISSUE WILL BE MONITORED. CONCLUSION: 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

    THIS IS THE THIRD OF THREE REPORTS (SAME USER FACILITY, DIFFERENT PRODUCT IDS). LINKED TO MFG REPORTS: 3004608878-2016-00345. 3004608878-2016-00346. RADIOLUCENT: THE STAFF WAS USING THE A2079 MAYFIELD INFINITY XR2 BASE UNIT AND A2114 MAYFIELD INFINITY XR2 SKULL CLAMP (RADIOLUCENT) ON A (B)(6) OLD MALE PATIENT UNDERGOING A CRANIOTOMY. AFTER THE PATIENT WAS PINNED, THE RESIDENT HEARD A LOUD CRACKING SOUND AND CAUGHT THE PATIENT¿S HEAD FROM FALLING. THERE WAS NO PATIENT INJURY DUE TO THE FAILURE AND BOTH DEVICES WERE REPLACED WITH OTHER ONES AND THE SURGERY PROCEEDED WITHOUT INCIDENT. THE STANDARD KNOB ASSEMBLY (ITEM # 437A2409 (REGULAR)) BROKE APART AFTER IT WAS SECURELY LOCKED INTO THE STARBURST ON THE A2114. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838671 MAYFIELD INFINITY XR2 BASE UNIT MAYFIELD FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 SKULL PINS