BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHO ANCHORAGE C-TUBE PLATE

    MDR report key: 2770295 · Received October 1, 2012

    Report

    Report Number
    9610905-2012-00031
    Event Type
    Injury
    Date Received
    October 1, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 7, 2012
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    DZE
    PMA / PMN Number
    K040891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DISCARDED BY DOCTOR. IF FURTHER INFO 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

    THE HOOK PORTION OF THE PLATE BROKE OFF. BROKEN PORTION WAS DISCARDED BY FACILITY. PT'S HEALTH WAS NOT COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORTHO ANCHORAGE C-TUBE PLATE DZE KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 01-30131 31651751

    Patients

    Seq Age Sex Outcome Treatment
    1 Other