BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3904222 · Received July 1, 2014

    Report

    Report Number
    2520274-2014-11900
    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
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN PLATE. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, MACHO, D., TSITSILONIS, S., SCHASER, K.-D., HAAS, N.P., AND WICHLAS, F. (2012). DISTAL RADIUS FRACTURES: VOLAR VS. DORSAL PLATING. INJURY, INT. J. CARE INJURED, 43, S25-S26. THE AIM OF THIS STUDY WAS TO EVALUATE THE COMPLICATION RATES OF VOLAR VERSUS DORSAL PLATE OSTEOSYNTHESIS AND INVESTIGATE THE INDICATIONS FOR DORSAL LOCKING PLATING. DATA FROM 285 OPERATIVELY TREATED DISTAL RADIUS FRACTURES WITH TA LOCKING PLATE (2.4 MM/3.5MM LCP, SYNTHES) WERE RETROSPECTIVELY EVALUATED. SIXTY PATIENTS RECEIVED A DORSAL PLATE OSTEOSYNTHESIS, 225 A VOLAR. MEAN AGE OF PATIENTS WAS 54.1 YEARS (SD 17.7). COMPLICATION RATE FOR THE VOLAR PLATING WAS 2.7 PERCENT, FOR THE DORSAL 10.0 PERCENT (P < 3.01). THE MOST COMMON COMPLICATIONS WERE IMPLANT RELATED SKIN IRRITATIONS AND REDUCTION OF RANGE OF MOTION. ONE TENDON RUPTURE OCCURRED. AN IMPLANT REMOVAL WAS MORE OFTEN NECESSARY AFTER DORSAL PLATING. THIS REPORT IS FOR AN UNKNOWN PLATE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). A THIS COMPLAINT INVOLVES ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382331 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1