BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3990821 · Received August 8, 2014

    Report

    Report Number
    2520274-2014-12657
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 10, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT NOT FOR DIAGNOSIS. HELMERHORST, G., KLOEN, P., (2012), ORTHOGONAL PLATING OF INTRA-ARTICULAR DISTAL RADIUS FRACTURES WITH AN ASSOCIATED RADIAL COLUMN FRACTURE VIA A SINGLE VOLAR APPROACH, INJURY, 43, 1307-1312. THIS REPORT IS FOR AN UNKNOWN PLATE. 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: HELMERHORST, G., KLOEN, P., (2012), ORTHOGONAL PLATING OF INTRA-ARTICULAR DISTAL RADIUS FRACTURES WITH AN ASSOCIATED RADIAL COLUMN FRACTURE VIA A SINGLE VOLAR APPROACH, INJURY, 43, 1307-1312. THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE THE RADIOGRAPHIC AND FUNCTIONAL OUTCOME OF ORTHOGONAL PLATING (TWO PLATES AT RIGHT ANGLES) VIA A SINGLE VOLAR APPROACH FOR FIXATION OF INTRA-ARTICULAR DISTAL RADIUS FRACTURES WITH AN ASSOCIATED RADIAL COLUMN FRACTURE. IN A RETROSPECTIVE STUDY 96 CONSECUTIVE PATIENTS WERE IDENTIFIED BETWEEN DECEMBER 2004 AND SEPTEMBER 2011. THESE PATIENTS WERE TREATED WITH DISTAL RADIUS PLATE 2.4 SYSTEMS. WITHIN THIS GROUP FOURTEEN PATIENTS RECEIVED AN ADDITIONAL FRAGMENT SPECIFIC RADIAL COLUMN FIXATION. THE FOURTEEN PATIENTS FORMED THE COHORT IN THIS STUDY. THE AVERAGE AGE WAS 52 YEARS AND THERE WERE SIX WOMEN AND EIGHT MEN. CLINICAL OUTCOMES, PATIENT WERE CHECKED FOR EARLY AND LATE COMPLICATIONS AT TWO WEEKS, SIX WEEKS, THREE MONTHS, AND MORE THAN ONE YEAR. AVERAGE FOLLOW UP LENGTH WAS 30 MONTHS. COMPLICATIONS INCLUDE ONE PATIENT WITH MALPOSITION OF THE FRACTURE WHICH REQUIRED A REVISION WITH AN ADDITIONAL THIRD PLATE. TWO PATIENTS UNDERWENT HARDWARE REMOVAL. ONE PATIENT COMPLAINED OF PAINFUL WRIST THEREFORE THE PLATE WAS REMOVED. THE SECOND PATIENT WANTED THE PLATE REMOVED BECAUSE THEY WERE AFRAID OF LIMITATIONS AS A DENTIST. THERE IS NOT SUFFICIENT INFORMATION TO FILE MULTIPLE REPORTS. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS COMPLAINT INVOLVES 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470575 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention