BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4694909 · Received April 15, 2015

    Report

    Report Number
    2520274-2015-12892
    Event Type
    Injury
    Date Received
    April 15, 2015
    Report Date
    April 10, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VOSS, B., ET AL (2012). LONG-TERM RESULTS OF STERNAL PLATE OSTEOSYNTHESIS FOR THE TREATMENT OF COMPLICATED STERNAL DEHISCENCE. CONFERENCE PUBLICATION OF 41ST ANNUAL MEETING OF THE GERMAN SOCIETY FOR CARDIOVASCULAR AND THORACIC SURGERY: ONE HEART-ONE TEAM, FREIBURG, GERMANY, 60, (VAR. PAGINGS). THIS REPORT IS FOR AN UNKNOWN PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, VOSS, B., ET AL (2012). LONG-TERM RESULTS OF STERNAL PLATE OSTEOSYNTHESIS FOR THE TREATMENT OF COMPLICATED STERNAL DEHISCENCE. CONFERENCE PUBLICATION OF 41ST ANNUAL MEETING OF THE GERMAN SOCIETY FOR CARDIOVASCULAR AND THORACIC SURGERY: ONE HEART-ONE TEAM, FREIBURG, GERMANY, 60, (VAR. PAGINGS). FROM 2005 TO 2011, THE SYNTHES TITANIUM PLATE FIXATION SYSTEM WAS USED IN 34 PATIENTS (MEAN 64+/-11 YEARS, RANGE 27-84 YEARS) WITH AN UNSTABLE THORAX AFTER MEDIAN STERNOTOMY. MEAN FOLLOW-UP WAS 2.3+/-1.8 YEARS. ONE PATIENT DIED DURING FOLLOW-UP, WHICH WAS NOT PLATE RELATED. IN FIVE PATIENTS, PLATES HAD TO BE REMOVED BECAUSE OF PRESTERNAL INFECTION AFTER 30-223 DAYS (MEDIAN 61 DAYS). ELEVEN PATIENTS COMPLAINED ABOUT ACTIVITY DEPENDENT PAIN AND FOUR PATIENTS COMPLAINED ABOUT CHRONIC STERNAL PAIN. IN SEVEN OF THEM, HARDWARE REMOVAL WAS PERFORMED AFTER 124-1825 DAYS (MEDIAN 301 DAYS). HOWEVER, THIS LEAD ONLY IN TWO PATIENTS TO A SIGNIFICANT PAIN REDUCTION. THE REMAINING FIVE PATIENTS NEEDED ADDITIONAL TREATMENT; E.G. ACUPUNCTURE FOR SUCCESSFUL PAIN REDUCTION. SOME PATIENTS REPORTED PERSISTENT THORACIC PAIN. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250684 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention