BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAYFIELD INFINITY XR2 TRI-STAR SWIVEL ADAPTOR

    MDR report key: 3980301 · Received June 5, 2014

    Report

    Report Number
    3004608878-2014-00084
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Report Date
    May 8, 2014
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    HBL
    PMA / PMN Number
    K130389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    ON AN UNK DATE, THE NURSE LOOSENED THE TRI-STAR ADAPTOR TO REMOVE FROM THE SKULL CLAMP ATTACHMENT AFTER THE PROCEDURE WAS COMPLETED ONCE IT WAS COMPLETELY REMOVED, IT WAS NOTICED THAT THE PRODUCT WAS BROKEN. THERE WAS NO PATIENT INJURY. THE ITEMS AND UNIT WERE NEVER DROPPED. THE XR2 UNIT HAS ONLY BEEN USED 2 TO 3 TIMES PRIOR TO THE INCIDENT. NO OTHER INFO WAS PROVIDED. ADDITIONAL INFO WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329863 MAYFIELD INFINITY XR2 TRI-STAR SWIVEL ADAPTOR MAYFIELD HBL INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1