BEUDAMED
    FDA Adverse Event Death Summary report: N

    CERCLAGE FIXATION

    MDR report key: 7562533 · Received June 1, 2018

    Report

    Report Number
    8030965-2018-54093
    Event Type
    Death
    Date Received
    June 1, 2018
    Report Date
    May 22, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT ID/INITIALS, GENDER, AND WEIGHT ARE UNKNOWN. PATIENT AGE: MEAN AGE OF 67 ± 11 YEARS. DATE OF EVENT: UNKNOWN. IMPLANTED DATE: UNKNOWN. EXPLANTED DATE: UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MELLY L. ET AL (2013) A NEW CABLE-TIE-BASED STERNAL CLOSURE DEVICE: INFECTIOUS CONSIDERATIONS. INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY VOLUME 17. PAGES 219-224. (SWITZERLAND). THE OBJECTIVE OF THIS RETROSPECTIVE DESCRIPTIVE AND COMPARATIVE STUDY IS TO ASSESS AND COMPARE THE FREQUENCY IN STERNAL WOUND INFECTION AND STERNAL DEHISCENCE POST-STERNOTOMY BETWEEN CONVENTIONAL WIRE AND CABLE-TIE-BASED CLOSURE TECHNIQUES IN PATIENTS AFTER CARDIAC SURGERY. BETWEEN FEBRUARY 1, 2011 TO JANUARY 31, 2012, 95 PATIENTS WITH A MEAN AGE OF 67 ± 11 YEARS WERE EXCLUSIVELY CLOSED WITH AN UNKNOWN SYNTHES PEEK-BASED STERNAL ZIPFIX, AND COULD BE COMPARED WITH 498 WHO WERE CLOSED WITH CONVENTIONAL WIRES (COMPETITOR DEVICE) DURING THE SAME PERIOD. THE MEAN AGE OF THE WHOLE POPULATION WAS 66 YEARS. INFECTIONS ARE RECORDED UP TO 12 MONTHS AFTER INITIAL CARDIAC OPERATION. THE FOLLOWING COMPLICATIONS ARE ASSOCIATED WITH THE SYNTHES PEEK-BASED STERNAL ZIPFIX GROUP: THREE CASES OF DEATH WAS REPORTED AT 30 DAYS POST-OP. THIS REPORT IS FOR AN UNKNOWN SYNTHES STERNAL ZIPFIX. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402098 CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R