BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/16MM

    MDR report key: 3093601 · Received May 6, 2013

    Report

    Report Number
    2520274-2013-02381
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    THE GENERAL PLATE AND SCREWS WERE REMOVED ON (B)(6) 2013. IMPLANT SURGERY WAS ON AN UNKNOWN DATE IN (B)(6) 2012. AN OFF-LABEL USE, BY THE SURGEON, OF A SINGLE PLATE WAS USED TO REPAIR THE TRANSVERSE FRACTURE OF THE STERNUM. IT WAS REPORTED PER PATIENT HISTORY THAT PATIENT WAS OSTEOPOROTIC, HAD SPONGY BONE, AND THE SCREWS DID NOT STAY SECURED WITHIN THE BONE. THE EXPLANT SURGERY WAS NEEDED. THE PLATE WAS PUSHING AGAINST THE SKIN AND THE BOTTOM TWO TO FIVE SCREWS WERE BACKING OUT OF PLACE. PATIENT STILL HAS SUBSTANTIAL DEFORMITY DUE TO THE ORIGINAL FRACTURE. THIS IS 2 OF 9 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197082 3.0MM TI STERNAL LCKNG SCREW SELF-DRILLING/16MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention