BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIC-INSTR F/STERNAL ZIPFIX

    MDR report key: 2822625 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01215
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDQ
    PMA / PMN Number
    K110789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4): MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. (B)(4): PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(4) PROVIDES INFORMATION FROM A FACILITY IN (B)(6) REGARDING THE STERNAL ZIPFIX APPLICATION INSTRUMENT. DURING A PROCEDURE, THE FINAL STERNAL ZIPFIX BEING IMPLANTED COULD NOT BE TENSIONED FULLY WITH THE APPLICATION INSTRUMENT. THERE WAS A GAP OF APPROXIMATELY 1MM IN THE STERNUM. CONSEQUENTLY, ALL THE ZIPFIX DEVICES WERE REMOVED AND THE CLOSURE WAS COMPLETED WITH WIRES. IT WAS REPORTED THAT THE SURGERY PROCEEDED TO COMPLETION, SMOOTHLY, WITHOUT FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APPLIC-INSTR F/STERNAL ZIPFIX ZIPFIX APPLICATION INSTRUMENT JDQ SYNTHES GMBH 7521227

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention