BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN

    MDR report key: 3173327 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03468
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K093772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UNKNOWN IMPLANT DATE IN (B)(6) 2013. PLACEHOLDER.

    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

    THIS IS REPORT 1 OF 17 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED: PATIENT HAD A REVISION SURGERY (APPROXIMATELY ONE MONTH AFTER INITIAL PROCEDURE) WHERE THE HARDWARE (PLATE AND SCREWS) WERE REMOVED DUE TO THE SCREWS CAUSING FLUID BUILDUP AROUND THE HEART, AS WELL AS BEING TOO LONG. IT WAS ALSO REPORTED THE PATIENT WAS RECOVERING WELL FROM THE REVISION SURGERY. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THIS IS 2 OF 17 DEVICES FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273764 TI STERNAL LOCKING STRAIGHT PLATE/13 HOLES/WITHOUT PIN HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention