BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3822934 · Received May 21, 2014

    Report

    Report Number
    2520274-2014-11522
    Event Type
    Injury
    Date Received
    May 21, 2014
    Date of Event
    November 19, 2013
    Report Date
    April 25, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF EVENT: VAN HOUTEN, A., HEESTERBEEK, P., VAN HEERWAARDEN, R., VAN TIENEN, T., WYMENGA, A. (2014) MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY: CAN DELAYED OR NONUNION BE PREDICTED? CLIN ORTHOP RELAT RES 472:1217-1223. ADDITIONAL DEVICE INFO: THIS REPORT IS FOR AN UNKNOWN LOCKING COMPRESSION PLATE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 JOURNAL ARTICLE: MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY: CAN DELAYED OR NONUNION BE PREDICTED? VAN HOUTEN, A., HEESTERBEEK, P., VAN HEERWAARDEN, R., VAN TIENEN, T., WYMENGA, A. (2014) MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY: CAN DELAYED OR NONUNION BE PREDICTED? CLIN ORTHOP RELAT RES 472:1217-1223. THIS WAS A RETROSPECTIVE REVIEW OF A TOTAL OF 206 MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMIES (HTOS) IN 185 PATIENTS (21 BILATERAL PROCEDURES) THAT WERE PERFORMED BETWEEN JANUARY 2007 AND DECEMBER 2009. THE STUDY POPULATION CONSISTED OF 138 MEN AND 47 WOMEN; MEAN AGE OF 48 +/- 9.7 YEARS. IN ALL OPEN WEDGE HTOS, MEDIAL PLATE FIXATION USING THE SYNTHES TOMOFIX WAS USED TO STABILIZE THE OSTEOTOMY. THE ARTICLE STUDIED THE LIKELIHOOD OF DELAYED AND NONUNION IN SMOKERS. OUT OF 19 REPORTED DELAYED/NONUNIONS, 11 OF THE PATIENTS WERE SMOKERS. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR A TOMOFIX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301385 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention