BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5393766 · Received January 27, 2016

    Report

    Report Number
    2520274-2016-10477
    Event Type
    Injury
    Date Received
    January 27, 2016
    Report Date
    January 22, 2016
    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

    YANG, K., WON, Y., KANG, D., OH, J., & KIM, S. (2015). ROLE OF APPOSITIONAL SCREW FIXATION IN MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR DISTAL TIBIAL FRACTURE. J ORTHOP TRAUMA, 29(9), 331-335. KOREA. THIS REPORT IS FOR UNKNOWN PLATE UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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: "YANG, K., WON, Y., KANG, D., OH, J., & KIM, S. (2015). ROLE OF APPOSITIONAL SCREW FIXATION IN MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS FOR DISTAL TIBIAL FRACTURE. J ORTHOP TRAUMA, 29(9), 331-335. KOREA" THE PURPOSE OF THE STUDY WAS TO DETERMINE THE EFFECT OF INTERFRAGMENTARY APPOSITIONAL (GAP CLOSING) SCREW FIXATION IN MINIMALLY INVASIVE PLATE OSTEOSYNTHESIS (MIPO) FOR DISTAL TIBIAL FRACTURES ON THE CLINICAL AND RADIOLOGIC RESULTS. THIRTY PATIENTS (GROUP A) OF THE 60 PATIENTS WERE TREATED WITH MIPO WITHOUT APPOSITIONAL SCREW FIXATION, AND THE OTHER 30 (GROUP B) WERE TREATED WITH THE SCREW. THE TERM "APPOSITIONAL SCREW" DESCRIBES A SCREW THAT IS USED TO APPROXIMATE THE 2 MAIN FRAGMENTS IN THE CLOSED METHOD GUIDED BY FLUOROSCOPY. AN APPOSITIONAL SCREW DOES NOT GENERATE FIRM INTERFRAGMENTARY COMPRESSION AS IN OPEN ANATOMIC REDUCTION AND RIGID INTERNAL FIXATION. THE MEAN FOLLOW-UP WAS 23.5 MONTHS (RANGE, 12-72 MONTHS) FOR GROUP A AND 17.4 MONTHS (RANGE, 12-66 MONTHS) FOR GROUP B. THE AVERAGE PATIENT AGE WAS 57 YEARS (RANGE, 27-84 YEARS), AND THERE WERE 28 MEN AND 32 WOMEN. GROUP A CONSISTED OF 16 MEN AND 14 WOMEN WITH AN AVERAGE AGE OF 60.3 (RANGE, 27-84) YEARS, WHEREAS GROUP B CONSISTED OF 12 MEN AND 18 WOMEN WITH AN AVERAGE AGE OF 54.2 (RANGE, 28-80) YEARS. THIRTY-EIGHT CASES WERE TREATED WITH A PERIARTICULAR DISTAL TIBIA LOCKING PLATE (COMPETITORS DEVICE), AND 22 CASES WERE TREATED WITH AN LOCKING COMPRESSION PLATE METAPHYSEAL PLATE ((B)(6)). FOUR CASES OF NONUNION DEVELOPED IN GROUP A AND HEALED AFTER THE PLACEMENT OF AN ADDITIONAL BONE GRAFT, 3 CASES WERE OF A1-TYPE FRACTURE, AND 1 CASE OF A2-TYPE FRACTURE. THIS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR A LOCKING COMPRESSION PLATE METAPHYSEAL PLATE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THE MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52058 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention