BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC 2980001 THREADED INSERTER

    MDR report key: 4330374 · Received December 9, 2014

    Report

    Report Number
    MW5039556
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    November 4, 2014
    Report Date
    November 26, 2014
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE A PART OF A SURGICAL INSTRUMENT BROKE OFF. AN X-RAY WAS TAKEN AND LOCATED THE BROKEN PIECE, WHICH WAS THEN REMOVED. ALL PIECES OF THE INSTRUMENT (CAT (B)(4), LOT #MA08H021) WERE ACCOUNTED FOR. SURGERY CONTINUED AND CLOSED WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792686 MEDTRONIC 2980001 THREADED INSERTER THREADED INSERTER LXH MA08H021

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR