BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXNEURO SCREW

    MDR report key: 2100224 · Received May 16, 2011

    Report

    Report Number
    1719045-2011-00247
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 5, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K042365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE NOT EXPLANTED. UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    DURING AN OCCIPITAL CRANIOTOMY SURGEON WAS INSERTING TWO MATRIXNEURO SCREWS AND THE HEADS BROKE OFF OF BOTH. SURGEON WAS UNABLE TO RETRIEVE THE TWO SCREWS BURRING THE SHAFT DOWN EVEN WITH THE BONE. SURGEON DID COMPLETE THE PROCEDURE. THE SHAFTS OF TWO SCREWS REMAIN IN THE PT'S BONE. THIS IS TWO OF TWO REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIXNEURO SCREW TI MATRIXNEURO SCREW JEY SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR