BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3887222 · Received June 20, 2014

    Report

    Report Number
    2520274-2014-11853
    Event Type
    Injury
    Date Received
    June 20, 2014
    Report Date
    June 9, 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 DIAGNOSIS. ¿TREATMENT OF COMPLEX FRACTURES OF THE DISTAL RADIUS: A PROSPECTIVE RANDOMIZED COMPARISON OF EXTERNAL FIXATION ¿VERSUS¿ LOCKED VOLAR PLATING" (2012). JEUDY, J. INJURY, 43;174-179. THIS REPORT IS FOR AN UNKNOWN VOLAR FIXED ANGLE PLATE /UNKNOWN LOT. 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 ABSTRACT, ¿TREATMENT OF COMPLEX FRACTURES OF THE DISTAL RADIUS: A PROSPECTIVE RANDOMIZED COMPARISON OF EXTERNAL FIXATION ¿VERSUS¿ LOCKED VOLAR PLATING (2012) JEUDY, J. INJURY, 43;174-179. WITHIN THE INCLUSION PERIOD (2006¿2009), 75 PATIENTS WERE FOLLOWED UP DURING 6 MONTHS WITH COMPLETE CLINICAL AND RADIOLOGICAL OBSERVATIONS. A TOTAL OF 39 PATIENTS WERE RANDOMLY ASSIGNED TO THE EF GROUP (HOFFMANN II,STRYKER1) (EVENTUALLY ASSOCIATED WITH PERCUTANEOUS PINNING) AND 36 TO THE ORIF GROUP USING A VOLAR FIXED-ANGLE PLATE (TITANIUM 2.4 DRP SYNTHES). THE FOLLOWING COMPLICATIONS OCCURRED IN THE ORIF GROUP: 11 MALUNIONS, 5 ULNAR VARIANCE INVERSIONS >2 MM,7 CASES WITH A VOLAR TILT >58, AND ONLY TWO CASES OF SECONDARY LOSS OF REDUCTION, BOTH OF WHICH FINALLY LED TO MODERATE ARTICULAR MALUNIONS WITH STEP-OFFS NOT EXCEEDING 2 MM. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR UNKNOWN VOLAR FIXED-ANGLE PLATE. THIS REPORT IS FOR 1 DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363050 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention