BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4 SL 8 HOLE, X PLATE

    MDR report key: 2013118 · Received March 10, 2011

    Report

    Report Number
    1032347-2011-00032
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    December 4, 2009
    Report Date
    December 4, 2009
    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

    IT WAS STATED THE DISSECTION OF THE STERNUM WAS NOT MADE IN THE MIDLINE OF THE PATIENT'S STERNUM, IT WAS MADE OFF CENTER. YET WHEN THE PLATES WERE PLACED ON THE STERNUM, THEY WERE POSITIONED AS THOUGH THE DISSECTION WAS MIDLINE. THEREFORE THE SCREWS WERE TOO CLOSE TO THE DISSECTION, IN CONJUNCTION WITH PREMATURE AMBULATION (PATIENT WAS DISCHARGED ON A WALKER 5 DAYS POST OP, AND HAVING A BMI OF 49, THE SCREWS PULLED OUT OF THE STERNUM. THERE IS NO INDICATION OF PLATE OR SCREW MALFUNCTION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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. THERE WERE 3 DIFFERENT PART NUMBERS THAT WERE EXPLANTED, PLEASE SEE MDR 1032347-2011-00031 TO 00033.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD PLATES AND SCREWS IMPLANTED FOR STERNAL CLOSURE ON (B)(6) 2009. THE SCREWS PULLED OUT OF THE BONE AND A REVISION SURGERY WAS PERFORMED ON (B)(6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 SL 8 HOLE, X PLATE BONE PLATE HRS BIOMET MICROFIXATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization