BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK

    MDR report key: 2945167 · Received February 6, 2013

    Report

    Report Number
    8030965-2013-00342
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A MANUFACTURING RECORD REVIEW CANNOT BE COMPLETED.

    Description of Event or Problem · 1

    APPROXIMATELY 2 WEEKS POST OP FROM A (B)(6) 2012 CABG PROCEDURE, REPORTEDLY, PATIENT SNEEZED VIGOROUSLY, AND POPPED OPEN SOME OF THE ZIP-FIX CLOSURE IMPLANTS. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 TO REMOVE THE ZIP-FIX IMPLANTS. PATHOLOGY CULTURES WERE TAKEN TO TEST FOR INFECTION. CULTURES WERE NEGATIVE. PATIENT WAS LEFT OPEN FOR ABOUT 24 HOURS, AND THE WOUND WAS TREATED WITH WOUNDVAC. PATIENT WAS REVISED THE FOLLOWING DAY. SURGEON USED STERNAL WIRES INSTEAD OF ZIP-FIX TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50468 STERNAL ZIPFIX WITH NEEDLE STERILE / 5 PACK STERNAL ZIPFIX WITH NEEDLE STERILE JDQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention