BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREADLOCK TS LOCKING PLATE

    MDR report key: 3367717 · Received September 17, 2013

    Report

    Report Number
    9610905-2013-00038
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    May 29, 2013
    Report Date
    August 27, 2013
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG.
    Product Code
    MQN
    PMA / PMN Number
    K032442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL INFORMED KLS MARTIN L.P. THAT THE PLATE WAS NOT AVAILABLE FOR EVALUATION. IF FURTHER INFORMATION IS ACQUIRED THAT ADDS VALUE TO THE CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    LOCKING PLATE WAS DISCOVERED TO BE BROKEN. IT WAS REMOVED AND REPLACED WITH A DIFFERENT TYPE OF STERNAL CLOSURE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467744 THREADLOCK TS LOCKING PLATE MQN KARL LEIBINGER MEDIZINTECHNIK GMBH AND CO. KG. 50-774-20-09

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other