BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2520274-2014-00875

    MDR report key: 3651021 · Received February 27, 2014

    Report

    Report Number
    2520274-2014-00875
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Report Date
    February 4, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INJURY, INT. J. CARE INJURED 44 (2013) 409¿416. DEVICE IS AN UNKNOWN PLATE, QUANTITY 1. CANNOT BE DETERMINED WITHOUT A PART NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ESPOSITO, J., SCHEMITSCH, E., SACCONE, M., STERNHEIM, A., AND KUZYK, P., (2013). EXTERNAL FIXATION VERSUS OPEN REDUCTION WITH PLATE FIXATION FOR DISTAL RADIUS FRACTURES: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS. INJURY, INT. J. CARE INJURED, 44, 409¿416. THE AUTHORS CONDUCTED A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS COMPARING EXTERNAL FIXATION TO OPEN REDUCTION INTERNAL FIXATION. POOLED MEAN DIFFERENCES WERE CALCULATED FOR THE FOLLOWING CONTINUOUS OUTCOMES: WRIST RANGE OF MOTION; RADIOGRAPHIC PARAMETERS; GRIP STRENGTH; AND DISABILITIES OF THE ARM, SHOULDER, AND HAND SCORE. POOLED RISK RATIOS WERE CALCULATED FOR RATES OF COMPLICATIONS AND REOPERATION. THIS ARTICLE SUMMARIZES FINDINGS FROM OTHER PUBLISHED ARTICLES REGARDING SYNTHES DEVICES (EXTERNAL FIXATOR AND PLATE) IN WHICH AN UNKNOWN NUMBER OF INFECTIONS, REOPERATIONS, OSTEOARTHRITIS, MALUNIONS, NERVE DEFICITS, COMPLEX REGIONAL PAIN SYNDROME, PAINFUL RETAINED HARDWARE, CARPAL TUNNEL SYNDROME, STIFFNESS, AND TENDONITIS WERE REPORTED. THE AUTHORS CONCLUDED THERE WAS LITTLE CLINICAL DIFFERENCE BETWEEN OPEN REDUCTION INTERNAL FIXATION WITH EXTERNAL FIXATION GROUPS AND PLATE FIXATION. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122433 HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1