BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3896946 · Received June 26, 2014

    Report

    Report Number
    2520274-2014-12136
    Event Type
    Injury
    Date Received
    June 26, 2014
    Report Date
    June 9, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LEE, Y.S. ET AL (2014) SERIAL ASSESSMENT OF WEIGHT-BEARING LOWER EXTREMITY ALIGNMENT RADIOGRAPHS AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY. THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY 30(3), 319-325. THIS REPORT IS FOR AN UNKNOWN QUANTITY OF UNKNOWN TOMOFIX PLATES. 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: SERIAL ASSESSMENT OF WEIGHT-BEARING LOWER EXTREMITY ALIGNMENT RADIOGRAPHS AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY. LEE, Y.S. ET AL (2014) SERIAL ASSESSMENT OF WEIGHT-BEARING LOWER EXTREMITY ALIGNMENT RADIOGRAPHS AFTER OPEN-WEDGE HIGH TIBIAL OSTEOTOMY. THE JOURNAL OF ARTHROSCOPIC AND RELATED SURGERY 30(3), 319-325. THE PURPOSE OF THIS STUDY WAS TO PERFORM A SERIAL ASSESSMENT OF THE RADIOLOGIC PARAMETERS OF THE MECHANICAL AXIS (MA) AND THE WEIGHT-BEARING LINE (WBL) USING A WEIGHT-BEARING ANTEROPOSTERIOR (AP) LONG-STANDING VIEW OF THE LOWER EXTREMITY TO DETERMINE WHETHER THE POSTOPERATIVE MA AND WBL CHANGE WITH TIME. A TOTAL OF 90 CONSECUTIVE LOWER LIMBS WERE EXAMINED RETROSPECTIVELY USING THE AP LONG-STANDING VIEW OF THE LOWER EXTREMITY OBTAINED FROM 120 PATIENTS WHO UNDERWENT OPEN WEDGE HIGH TIBIAL OSTEOTOMY (OWHTO) FROM 2007-2011. PATIENTS WERE IMPLANTED USING A LOCKING COMPRESSION PLATE SYSTEM (TOMOFIX, SYNTHES) WITH 6.5MM SCREWS. SEVEN (7) PATIENTS WERE EXCLUDED FROM THE STUDY DUE TO COMPLICATIONS SUCH AS BONE GRAFT COLLAPSE OR BROKEN SCREWS, MAL-UNION, OR POSTOPERATIVE NON-UNION. THIS REPORT IS 1 OF 2 FOR COMPLAINT COM-057180. THIS REPORT IS FOR AN UNKNOWN TOMOFIX PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374801 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention