BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3905163 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-12173
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN VOLAR LOCKING PLATE. (B)(6). 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: LOCKING DISTAL RADIUS PLATE ¿ EARLY RESULTS FROM INDIA. SHETTY, S., KUMAR, A., KIRAN, K., KINI, A. (2011) LOCKING DISTAL RADIUS PLATE ¿ EARLY RESULTS FROM INDIA. J TRAUMA 71(5):1359-1363. THIS WAS A PROSPECTIVE STUDY FROM (B)(6) 2008 TO (B)(6) 2009 OF 23 PATIENTS (14 MEN AND 9 WOMEN AVERAGE AGE OF 35.04 YEARS) WITH INTRA-ARTICULAR DISTAL RADIUS FRACTURES. ALL THE FRACTURES UNDERWENT ORIF WITH 2.4 VOLAR LOCKING DISTAL RADIUS PLATE (SYNTHES). ONLY ONE PATIENT HAD A DELAYED UNION AT 36 WEEKS. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN VOLAR LOCKING PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382391 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1