BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5029123 · Received August 25, 2015

    Report

    Report Number
    2520274-2015-15436
    Event Type
    Injury
    Date Received
    August 25, 2015
    Report Date
    August 18, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LI S.L., LU Y., WANG M.Y. (2015) IS CROSS-SCREW FIXATION SUPERIOR TO PLATE FOR RADIAL NECK FRACTURES? THE BONE AND JOINT JOURNAL;97-B:830-835. THIS REPORT IS FOR UNKNOWN 2.4 MM LOCKING COMPRESSION PLATES, UNKNOWN QUANTITY, UNKNOWN LOT. (B)(4) FOUR PATIENTS DEVELOPED HETEROTOPIC OSSIFICATION AT THREE TO FOUR MONTHS POSTOPERATIVELY, OF WHICH THREE (10.3%) WERE IN THE PLATE GROUP. 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. 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 LITERATURE ARTICLE, LI S.L., LU Y., WANG M.Y.(2015). IS CROSS-SCREW FIXATION SUPERIOR TO PLATE FOR RADIAL NECK FRACTURES? BONE JOINT J 2015;97-B:830-5. THIS STUDY COMPARES THE OUTCOMES OF TWO METHODS OF FIXATION OF DISPLACED FRACTURES OF THE RADIAL NECK. THE 58 PATIENTS WITH A MEAN AGE OF 38.5 YEARS (18 TO 56), WERE TREATED IN A NONRANDOMISED STUDY WITH SCREWS (N = 29) OR A PLATE AND SCREWS (N = 29) ACCORDING TO THE SURGEON铠PREFERENCE. THE PATIENTS WERE REVIEWED AT ONE YEAR. RADIOGRAPHS AND FUNCTIONAL EVALUATIONS WERE CARRIED OUT UP TO ONE YEAR POST-OPERATIVELY, USING THE BROBERG AND MORREY FUNCTIONAL EVALUATION SCORE, RANGE OF MOVEMENT, AND ASSESSMENT OF COMPLICATIONS. RESULTS: ALL FRACTURES HEALED WITHIN FOUR MONTHS OF SURGERY. THERE WERE NO WOUND INFECTIONS, NERVE INJURIES, LOSS OF REDUCTION, OR FAILURES OF FIXATION IN ANY PATIENTS. FOUR PATIENTS DEVELOPED HETEROTOPIC OSSIFICATION AT THREE TO FOUR MONTHS POSTOPERATIVELY, OF WHICH ONE (3.4%) WAS IN THE SCREW GROUP AND THREE (10.3%) WERE IN THE PLATE GROUP (FISHER'S EXACT TEST, P = 0.61). THIS IS REPORT #2 OF 2 FOR (B)(4). THIS REPORT IS FOR UNKNOWN 2.4 MM LOCKING COMPRESSION PLATES AND REFERS TO THE HETEROTOPIC OSSIFICATION AT THREE TO FOUR MONTHS POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562697 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention