BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 3901714 · Received May 5, 2014

    Report

    Report Number
    3004608878-2014-00052
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 5, 2014
    Report Date
    April 11, 2014
    Manufacturer
    INTEGRA LIFESCIENCES (LIMITED) LIMITED
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN SKULL PINS/MAYFIELD FOR A POSTERIOR CERVICAL FORAMINOTOMY (PCF) AND THE MAYFIELD HANDLE GAVE WAY. THE PATIENT'S HEAD AND NECK MOVED DURING SURGERY. THERE WAS NO HARM. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2014, THE CUSTOMER PROVIDED THE FOLLOWING: ON (B)(6) 2014, THE (B)(6) FEMALE PATIENT'S HEAD MOVED IN THE MAYFIELD DURING SURGERY. THE LENGTH OF TIME THE PRODUCT WAS IN USE BEFORE THE EVENT OCCURRED WAS REPORTED AS DURING THE CASE, TIME FRAME UNKNOWN. THE PATIENT WAS INITIALLY POSITIONED PRONE. THE SURGEON BROKE SCRUB AND INSPECTED THE MAYFIELD. THE PATIENT WAS REPOSITIONED. THE HANDLE WAS TAPED SO IT COULD NOT MOVE AGAIN. SURGICAL DELAY WAS DEFINED AS "LONG ENOUGH TO FIX THE MAYFIELD, PROBABLY 5 TO 10 MINUTES. THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THE SURGICAL DELAY. SURGERY WAS COMPLETED. PATIENT OUTCOME WAS "FINE-NO INJURY". THE LOT NUMBER OR CODE OF THE PRODUCT WAS UNKNOWN. THE SURGERY WAS NOT PERFORMED WITH A STEREOTAXY DEVICE. INTEGRA ADULT REUSABLE SKULL PINS (A1047, LOT NUMBER UNKNOWN) WERE ALSO USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268142 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS FWZ INTEGRA LIFESCIENCES (LIMITED) LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR