BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5892952 · Received August 22, 2016

    Report

    Report Number
    2520274-2016-14264
    Event Type
    Injury
    Date Received
    August 22, 2016
    Report Date
    August 17, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: SCHROTER, S. ET AL (2015). SMOKING AND UNSTABLE HINGE FRACTURES CAUSE DELAYED GAP FILLING IRRESPECTIVE OF EARLY WEIGHT BEARING AFTER OPEN WEDGE OSTEOTOMY. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, 31, 254-265. THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE / UNKNOWN QUANTITY / UNKNOWN LOT. UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. 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, SCHROTER, S. ET AL (2015). SMOKING AND UNSTABLE HINGE FRACTURES CAUSE DELAYED GAP FILLING IRRESPECTIVE OF EARLY WEIGHT BEARING AFTER OPEN WEDGE OSTEOTOMY. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, 31, 254-265. THE AUTHORS CONDUCTED A PROSPECTIVE STUDY TO EXAMINE THE OSTEOTOMY GAP FILLING RATE WITH NEW BONE AFTER OPEN WEDGE HIGH TIBIAL OSTEOTOMY (HTO) WITHOUT BONE GRAFT USING SYNTHES TOMOFIX PLATE AND THE EFFECTS OF SMOKING, LATERAL HINGE FRACTURE, AND EARLY FULL WEIGHT BEARING. BETWEEN DECEMBER 2008 AND OCTOBER 2010, 47 MEN AND 23 WOMEN WITH A MEAN AGE OF 46 YEARS (RANGE, 19 TO 59 YEARS) WERE SELECTED IN THE STUDY. RADIOLOGIC FOLLOW-UP EXAMINATIONS TOOK PLACE POSTOPERATIVELY, AFTER 6 AND 12 WEEKS, AND AFTER 6, 12, AND 18 MONTHS TO MEASURE OSTEOTOMY GAP FILLING AT EACH FOLLOW-UP. POST-OPERATIVE BONE HEALING WAS COMPARED IN SMOKERS VERSUS NONSMOKERS. SERIOUS INJURY RESULTS INCLUDED LATERAL HINGE FRACTURES THAT WERE FOUND IN 27 PATIENTS AFTER OPEN WEDGE HTO. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546359 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention