BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 10730917 · Received October 23, 2020

    Report

    Report Number
    3004608878-2020-00628
    Event Type
    Malfunction
    Date Received
    October 23, 2020
    Report Date
    September 30, 2020
    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 · 0

    UNIQUE DEVICE IDENTIFICATION: (01)10381780267997(11)150320(10)041(21)014277, MAYFIELD BASE UNIT WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - THE DHR SHOWS NO ABNORMALITIES RELATED TO THE REPORTED FAILURE. THE REPORTED COMPLAINT WAS CONFIRMED FROM THE EVALUATION OF THE RETURNED PRODUCT. THE SHOCK CUSHION AND 1/4IN PIN ARE WORN. THE ADJUSTMENT WRENCH, BUTTON HEAD SCREW AND THE 6IN TRANSITIONAL MEMBER WERE NOT RETUNED. THE SHOCK CUSHION WAS NOT FUNCTIONING PROPERLY. THE OBSERVED CONDITION IS LIKELY CAUSED BY WEAR AND TEAR. THE DEFINITE ROOT CAUSE CANNOT BE RELIABLY DETERMINED.

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED. LINKED TO MFG REPORT NUMBERS: 3004608878-2020-00629 AND 3004608878-2020-00627.

    Description of Event or Problem · 1

    THIS IS 3 OF 3 REPORTS. IT WAS REPORTED THAT THE CAM LOCK WAS LOOSE AND NOT WORKING WELL. THERE WAS NO KNOWN PATIENT INJURY OR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190261 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES CORPORATION OH/USA 041

    Patients

    Seq Age Sex Outcome Treatment
    1