BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 5892862 · Received August 22, 2016

    Report

    Report Number
    2520274-2016-14262
    Event Type
    Injury
    Date Received
    August 22, 2016
    Report Date
    August 18, 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: AKAMATSU, Y., KOBAYASHI, H., KUSAYAMA, Y., KUMAGAI, K. AND SAITO, T. (2016). COMPARATIVE STUDY OF OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH AND WITHOUT A COMBINED COMPUTED TOMOGRAPHY BASED AND IMAGE-FREE NAVIGATION SYSTEM. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, HTP://DX.DOI.ORG/10.1016/J.ARTHRO.2016.02.018. D1, D2, D3, D4: 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, AKAMATSU, Y., KOBAYASHI, H., KUSAYAMA, Y., KUMAGAI, K. AND SAITO, T. (2016). COMPARATIVE STUDY OF OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH AND WITHOUT A COMBINED COMPUTED TOMOGRAPHY BASED AND IMAGE-FREE NAVIGATION SYSTEM. ARTHROSCOPY: THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY, HTP://DX.DOI.ORG/10.1016/J.ARTHRO.2016.02.018. THE AUTHORS CONDUCTED A PROSPECTIVE RANDOMIZED TRIAL TO DETERMINE WHETHER A COMBINED COMPUTED TOMOGRAPHY (CT) BASED AND IMAGE-FREE NAVIGATION SYSTEM RESULTS IN BETTER CORONAL AND SAGITTAL ALIGNMENT THAN THE CONVENTIONAL METHOD FOR PERFORMING OPENING-WEDGE HIGH TIBIAL OSTEOTOMY (OWHTO) AND WHETHER CT-BASED NAVIGATION RESULTS IN ACQUISITION OF AN ACCURATE OSTEOTOMY PLANE. IN BOTH METHODS, SYNTHES TOMOFIX PLATE WAS USED FOR FIXATION. SIXTY-TWO CONSECUTIVE KNEES (46 WOMEN, 16 MEN ) UNDERWENT OWHTO BETWEEN SEPTEMBER 2010 AND AUGUST 2012. THE PATIENTS WERE RANDOMLY DIVIDED INTO A COMBINED CT-BASED NAVIGATION AND IMAGE-FREE NAVIGATED GROUP (MEAN AGE 63.6 YEARS) AND A CONVENTIONAL GROUP (MEAN AGE 66.3 YEARS) OF 31 PATIENTS EACH. ALL PATIENTS UNDERWENT RADIOGRAPHIC FOLLOW-UP EVALUATIONS AT 24 MONTHS. SERIOUS INJURY RESULTS INCLUDED LATERAL CORTICAL HINGE FRACTURE (9, NAVIGATED GROUP AND 6, CONVENTIONAL GROUP). THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545602 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention