BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL LOCKING PLATE

    MDR report key: 2993892 · Received March 1, 2013

    Report

    Report Number
    9610905-2013-00005
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    December 28, 2012
    Report Date
    February 2, 2013
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG
    Product Code
    HRS
    PMA / PMN Number
    K032413
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT DISCARDED BY FACILITY. 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

    REVISIONAL SURGERY PERFORMED DUE TO DESCRIBED GRINDING, PINCHING SENSATION. UPON OPENING THE PT, IT WAS DISCOVERED THAT THE PLATE WAS BROKEN IN TWO PLACES, OVER THE JOINT OF THE RIB AND STERNUM. HYPOTHESIS IS THAT THE RIBS MOVED, AND EVENTUALLY BROKE THE PLATE. PLATE WAS DISCARDED. PT HEALTH WAS NOT COMPROMISED. STERNUM WAS HEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89491 STERNAL LOCKING PLATE HRS KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG 24-025-07-09 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other