BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMF LEVEL ONE

    MDR report key: 8217431 · Received January 4, 2019

    Report

    Report Number
    9610905-2018-00344
    Event Type
    Injury
    Date Received
    January 4, 2019
    Report Date
    December 12, 2018
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    JEY
    PMA / PMN Number
    K950045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE PART NUMBER WAS NOT PROVIDED AT THE TIME OF THIS REPORT AND IT IS NOT CLEAR THAT THIS IS A KLS MARTIN L.P. PRODUCT. REFERENCE EXEMPTION NUMBER E2017029.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLATE BROKE. IT IS EXPECTED TO BE REMOVED (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    DEVICE MATERIAL NUMBER NOR LOT NUMBER WAS IDENTIFIED THEREFORE COMPLAINT RATE, REVIEW OF DEVICE HISTORY RECORDS AND RISK FILE WAS NOT POSSIBLE. THE ROOT CAUSE FOR THE FAILURE CANNOT BE DETERMINED SINCE NEITHER MATERIAL NOR LOT NUMBER WERE PROVIDED AND THE DEVICE WAS NOT RETURNED. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10021 CMF LEVEL ONE PLATE JEY KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other