BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LDR SPINE ROI-C INTERBODY FUSION DEVICE

    MDR report key: 3150030 · Received May 29, 2013

    Report

    Report Number
    3004903783-2013-00007
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    March 25, 2013
    Report Date
    May 29, 2013
    Manufacturer
    LDR MEDICAL
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FDA NOTIFIED LDR SPINE, INC. THAT A VOLUNTARY MEDWATCH REPORT (B)(4) HAD BEEN RECEIVED BY THE FDA FOR AN EVENT. THE EVENT DESCRIPTION IS THAT AN ANCHOR PLATE WAS FOUND BROKEN AT A POST OPERATIVE CHECK UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233620 LDR SPINE ROI-C INTERBODY FUSION DEVICE CERVICAL INTERBODY FUSION DEVICE KWP LDR MEDICAL MC1005T 273232/14

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK