BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD ULTRA BASE UNIT

    MDR report key: 3012879 · Received March 1, 2013

    Report

    Report Number
    1222895-2013-00008
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 20, 2013
    Report Date
    March 1, 2013
    Manufacturer
    INTERGRA LIFESCIENCE CORPORATON OH/USA
    Product Code
    HBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A MAYFIELD BASE UNIT WAS REPORTED TO HAVE SLIPPED DURING A 3 LEVEL POSTERIOR CERVICAL FUSION. THE PT WAS REPOSITIONED DURING THE PROCEDURE. THE EVENT OCCURRED APPROXIMATELY 7 MINUTES AFTER THE CLAMP WAS APPLIED AND IT CAUSED THE SURGERY TO BE DELAYED 20-25 MINUTES. THE PT WAS ANESTHETIZED WHEN THE EVENT OCCURRED. THE PT DID NOT INCUR AN INJURY AS A RESULT OF THIS EVENT. DISPOSABLE MAYFIELD PINS A1072 WERE USED AND THERE WAS NO STEREOTAXY DEVICE IN USE FOR THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90663 MAYFIELD ULTRA BASE UNIT BASE UNITS AND ADAPTERS HBL INTERGRA LIFESCIENCE CORPORATON OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR