BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/14MM

    MDR report key: 3070576 · Received October 24, 2012

    Report

    Report Number
    8030965-2012-01731
    Event Type
    Injury
    Date Received
    October 24, 2012
    Report Date
    September 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PT HAD A PFO CLOSURE ON (B)(6) 2011 COMPLETED AT (B)(6). THE SURGEON COULD NOT USE STERNAL WIRE FOR CLOSURE DUE TO NICKEL ALLERGY, AND CLOSE TO USE STERNAL PLATES. ON AN UNK DATE, PT PRESENTED AT (B)(6), COMPLAINING OF PAIN AND BULKINESS OF THE PLATES. PT ASKED TO HAVE THE HARDWARE REMOVED. SURGEON RETURNED PT TO THE OPERATING ROOM AND REMOVED 5 PLATES AND 25 SCREWS ON (B)(6) 2012. STERNUM IS REPORTEDLY FUSED AND NO MORE TREATMENT IS ANTICIPATED. THIS IS 19 OF 30 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/14MM STERNAL LCKNG SCREW HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention PLATE| SCREW