BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STAR PLATE-12 HOLES

    MDR report key: 6119542 · Received November 21, 2016

    Report

    Report Number
    2520274-2016-15451
    Event Type
    Injury
    Date Received
    November 21, 2016
    Report Date
    November 2, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: HWC. (B)(4). 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A STERNAL RECONSTRUCTION SURGERY ON (B)(6) 2016. THE PATIENT WAS BROUGHT BACK IN ON (B)(6) 2016 FOR AN EVALUATION DUE TO PAIN. THE PATIENT HAD UNDERGONE CARDIAC SURGERY ON AN UNKNOWN DATE. THE SURGEON DECIDED TO REMOVE ALL THE EXISTING INTACT HARDWARE FOUR (4) PLATES AND TWENTY-FIVE (25) LOCKING SCREWS. IT WAS THEN NOTICED THAT THE PATIENT ALSO HAD A NONUNION OF THE STERNUM. THE PATIENT WAS REVISED TO A CONSTRUCT WHICH INCLUDED STERILE PLATES AND SCREWS. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY AND NO PATIENT HARM. THIS REPORT IS 1 OF 29 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769623 TI STERNAL LOCKING STAR PLATE-12 HOLES CERCLAGE FIXATION HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention