BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4 SL 4 HOLE L PLATE 100 DEG

    MDR report key: 2013204 · Received March 10, 2011

    Report

    Report Number
    1032347-2011-00035
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K033740
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THERE IS NO INDICATION OF PLATE OR SCREW FAILURE. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THREE DIFFERENT PART NUMBERS WERE EXPLANTED WITH THE STERNUM. SEE MDRS 1032347-2011-00034 TO 00036.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PLATES, SCREWS AND WIRES IMPLANTED FOR STERNAL CLOSURE. THE PATIENT DEVELOPED AN INFECTION, WHICH RESULTED IN 6 REVISION SURGERIES FROM (B)(6) 2009, WHERE WIRES WERE REMOVED AND REPLACED. AS THE INFECTION WAS DEEP IN THE BONE, THE DOCTOR THEN DECIDED TO REMOVE THE ENTIRE STERNUM, THUS REMOVING THE PLATES AND SCREWS FROM THE PATIENT AS THEY WERE STILL IN THE STERNUM, ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 SL 4 HOLE L PLATE 100 DEG BONE PLATE HRS BIOMET MICROFIXATION UKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization