BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WIRE

    MDR report key: 2882866 · Received December 20, 2012

    Report

    Report Number
    2520274-2012-04264
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    September 28, 2012
    Report Date
    November 22, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    DYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH 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

    PATIENT HAD A TRIPLE CORONARY ARTERY BYPASS GRAFT PROCEDURE PERFORMED ON (B)(6) 2012. THE SAME DAY, AS THE PATIENT WAS STILL PRESENT AT THE HOSPITAL, THE PATIENT HEARD A POP SOUND AND NOTIFIED MEDICAL STAFF. IT WAS DETERMINED THAT THE PATIENT HAD OPENED BACK UP UNDERNEATH THE STAPLES. PATIENT WAS SLENDER IN SIZE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 AND THE FOUR ZIPFIX AND TWO DOUBLE WIRES THAT HAD BROKEN WERE REMOVED. THE SURGEON REVISED THE PATIENT WITH A COMBINATION OF SINGLE AND DOUBLE WIRES. THIS IS 6 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WIRE DYX SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ZIPFIX, WIRES