BEUDAMED
    FDA Adverse Event Other Summary report: N

    2.4 STERNALOCK 4 "L" 1.2, 100 DEGREE PLATE

    MDR report key: 1030555 · Received April 15, 2008

    Report

    Report Number
    1032347-2008-00013
    Event Type
    Other
    Date Received
    April 15, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 17, 2008
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    K011076
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFO IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADD'L INFO 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. TWO DIFFERENT PLATES (2 "X" PLATES AND 2 "L" PLATES WERE USED IN THIS PROCEDURE. PLEASE SEE 1032347-2008-0012 FOR THE X PLATE REPORT.

    Description of Event or Problem · 1

    FOUR PLATES AND 24 SCREWS WERE IMPLANTED ON (B) (6) 2008 FOR STERNAL CLOSURE. ON (B) (6) 2008, IT WAS NOTICED THE MIDDLE 1/3 OF LEFT HEMISTERNA PULLED OFF THE COSTAL CARTILAGE AND WAS STILL ATTACHED TO THE MIDDLE PLATES, THE UPPER FOUR SCREWS AND LOWER TWO SCREWS ALL PULLED OUT OF THE UPPER AND LOWER STERNAL REMNANT ON LEFT SIDE. PT REQUIRED A MUSCLE FLAP CLOSURE ON (B) (6) 2008. IT WAS NOTED THE PT'S BONE WAS OSTEOPOROTIC AND THIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 STERNALOCK 4 "L" 1.2, 100 DEGREE PLATE BONE PLATE HRS BIOMET MICROFIXATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization HOLD THE PLATES| SCREWS (2.4MMX12MM, CATALOG #71-2412) WERE USED TO