BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 4087692 · Received September 14, 2014

    Report

    Report Number
    2520274-2014-13510
    Event Type
    Injury
    Date Received
    September 14, 2014
    Date of Event
    December 7, 2011
    Report Date
    September 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN EXPERT NAIL SYSTEM. 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. 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: HATZIDAKIS, A., ET AL., (2011), ANGULAR-STABLE LOCKED INTRAMEDULLARY NAILING OF TWO-PART SURGICAL NECK FRACTURES OF THE PROXIMAL PART OF THE HUMERUS. A MULTICENTER RETROSPECTIVE OBSERVATIONAL STUDY, JOURNAL OF BONE AND JOINT SURGERY, 93, 2172-2179. BETWEEN 2003 AND 2007, FORTY-EIGHT PATIENTS WITH DISPLACED NEER TWO-PART SURGICAL NECK PROXIMAL HUMERAL FRACTURES WERE MANAGED WITH ANTEGRADE INTRAMEDULLARY LOCKED NAILING. TEN PATIENTS WERE LOST TO FOLLOW-UP, LEAVING THIRTY-EIGHT PATIENTS AVAILABLE FOR INCLUSION IN THE PRESENT STUDY. NINE PATIENTS WERE IN THE SYNTHES GROUP AND THE OTHER TWENTY-NINE WAS IN A COMPETITORS GROUP. THE SYNTHES GROUP RECEIVED AN EXPERT NAIL SYSTEM. THE AGE RANGE WAS 46 TO 87 YEARS AND THERE WERE THREE MALE AND SIX FEMALE PATIENTS. FOLLOW UPS WERE COMPLETED ON AVERAGE AT TWENTY-ONE MONTHS. COMPLICATIONS IN THE SYNTHES GROUP WERE THAT THERE WERE REPORTS OF PAIN. SOME PATIENTS HAD REVISIONS COMPLETE OF THE DEVICE HOWEVER, IT WASN¿T REPORTED IF THEY WERE IN THE SYNTHES GROUP OR COMPETITORS GROUP. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568112 NAIL, FIXATION, BONE JDS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention