BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERCLAGE FIXATION

    MDR report key: 7625137 · Received June 21, 2018

    Report

    Report Number
    8030965-2018-54481
    Event Type
    Injury
    Date Received
    June 21, 2018
    Report Date
    May 24, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SILAYEV AA, KANDAUROV AE, ZORIN YEV, NAZARYAN KE, CHVOKOV AV (2014). STERNAL CLOSURE USING PLASTIC LIGATURES. CARDIOLOGY AND CARDIOVASCULAR SURGERY. VOLUME 5. PAGES 85-87. 510K: THIS REPORT IS FOR AN UNKNOWN ZIPFIX IMPLANT/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURE DATE IS UNKNOWN. 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: SILAYEV AA, KANDAUROV AE, ZORIN YEV, NAZARYAN KE, CHVOKOV AV (2014). STERNAL CLOSURE USING PLASTIC LIGATURES. CARDIOLOGY AND CARDIOVASCULAR SURGERY. VOLUME 5. PAGES 85-87. (RUSSIA) THE PURPOSE OF THE STUDY WAS TO ANALYZE THE RESULTS OF THE USE OF PLASTIC LIGATURES FOR OSTEOSYNTHESIS IN PRACTICAL HEART SURGERY. FROM JANUARY OF 2012 THROUGH OCTOBER OF 2013, 320 PATIENTS WHO HAD STERNAL CLOSURE USING PLASTIC LIGATURES BASED ON POLYETHERETHERKETONE (PEEK) FOLLOWING HEART SURGERIES WERE INCLUDED IN THE STUDY. THERE WERE 253 MALES AND 67 FEMALES WITH AN AVERAGE AGE 58.9± 13.4 YEARS OLD. SURGICAL OPERATIONS INCLUDED: CORONARY ARTERY BYPASS SURGERIES (276 CASES, AMONG WHICH 68 WERE PERFORMED WITHOUT ASSISTED CIRCULATION) AND HEART VALVE REPLACEMENT OPERATIONS (44, AMONG WHICH THERE WERE 22 PATIENTS WITH SEPTIC HEART VALVE ENDOCARDITIS). STERNAL CLOSURE WAS DONE USING AN UNKNOWN SYNTHES ZIPFIX SYSTEM. THE RESULTS OF STERNAL CLOSURE USING STERNAL ZIPFIX FULLY BIOCOMPATIBLE PLASTIC LIGATURES WERE ANALYZED IN 320 PATIENTS WITH DIFFERENT HEART SURGERY PROFILES FOLLOWING LONGITUDINAL MIDLINE STERNOTOMY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 7 PATIENTS REQUIRED A SECOND BREASTBONE OSTEOSYNTHESIS 6 PATIENTS HAVE STERNAL DIASTASIS ACCOMPANIED BY THE ONSET OF AN INFECTIOUS PROCESS AND THE DEVELOPMENT OF STERNOMEDIASTINITIS. THEY REQUIRED PROTRACTED HOSPITAL TREATMENT, EXTENSIVE ANTIBIOTIC THERAPY, AND MULTIPLE POSTOPERATIVE WOUND DEBRIDEMENTS ON THE THORAX, ACCOMPANIED BY SUBSEQUENT STERNAL REOSTEOSYNTHESIS AND LOCAL TISSUE THORACOPLASTY. 1 PATIENT HAD STERNAL DIASTASIS WITH A NEED FOR A SECOND OSTEOSYNTHESIS AS A RESULT OF AN INJURY ON THE 3RD DAY POST-OP PERIOD. THIS REPORT IS FOR ONE DEVICE- AN UNKNOWN SYNTHES ZIPFIX SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467261 CERCLAGE FIXATION JDQ OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention