BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STAR PLATE-12 HOLES

    MDR report key: 3200217 · Received July 1, 2013

    Report

    Report Number
    2520274-2013-03974
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    JDQ
    PMA / PMN Number
    K010943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT WAS REIMPLANTED WITH 3 STERNAL PLATES AND 28 SELF DRILLING STERNAL SCREWS DUE TO STERNAL INSTABILITY. PATIENT RETURNED TO SURGEON COMPLAINING OF ONGOING PAIN. ON (B)(6) 2013, SURGEON RETURNED THE PATIENT TO THE OPERATING ROOM, REMOVED 3 STERNAL PLATES AND 28 UNKNOWN STERNAL SCREWS. PATIENT IS REPORTEDLY HEALED, NO NEW HARDWARE WAS PLACED. DURING THE REMOVAL, ONE SCREWDRIVER BROKE. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299171 TI STERNAL LOCKING STAR PLATE-12 HOLES JDQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention