BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-03973

    MDR report key: 3200227 · Received July 1, 2013

    Report

    Report Number
    2520274-2013-03973
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 4, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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. THIS REPORT IS FOR 28 3.0 MM SELF DRILLING TITANIUM STERNAL SCREWS. 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 OR, 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 REPORT IS FOR TWENTY-EIGHT (28) 3.0 MM SELF DRILLING TITANIUM STERNAL SCREWS. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299969 HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention