BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 6477306 · Received April 10, 2017

    Report

    Report Number
    2520274-2017-11241
    Event Type
    Injury
    Date Received
    April 10, 2017
    Report Date
    April 5, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS. VOS, R ET AL (2016) TITANIUM PLATE FIXATION VERSUS CONVENTIONAL CLOSURE FOR STERNAL DEHISCENCE AFTER CARDIAC SURGERY. THORACIC AND CARDIOVASCULAR SURGEON. THIS REPORT IS FOR AN UNKNOWN TITANIUM STERNAL FIXATION SYSTEM. (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICES WERE RETURNED AND NO LOT NUMBERS OR PART NUMBERS WERE PROVIDED. (B)(4). 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: VOS, R ET AL (2016) TITANIUM PLATE FIXATION VERSUS CONVENTIONAL CLOSURE FOR STERNAL DEHISCENCE AFTER CARDIAC SURGERY. THORACIC AND CARDIOVASCULAR SURGEON. THE AIM OF THIS STUDY IS TO DETERMINE WHETHER CLOSURE OF THE STERNUM WITH TITANIUM PLATES IS SUPERIOR TO CONVENTIONAL CLOSURE IN PATIENTS WITH STERNAL DEHISCENCE WITH OR WITHOUT PREVIOUSLY TREATED MEDIASTINITIS. ALL PATIENTS OPERATED ON USING THE TITANIUM STERNAL FIXATION SYSTEM (SYNTHES, INC., (B)(4)) BETWEEN MARCH 2010 AND AUGUST 2013. TWENTY (20) PATIENTS WERE INCLUDED IN THE STERNAL PLATING. IN THE STERNAL PLATING GROUP, 4 PATIENTS HAD PAIN COMPLAINTS AND WERE STILL PRESENT AT FOLLOW-UP IN (B)(6) 2014. PLATE REMOVAL WAS SEEN IN 3 CASES IN THE STERNAL PLATING GROUP. THIS REPORT IS FOR AN UNKNOWN TITANIUM STERNAL FIXATION SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260241 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention