BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4610269 · Received March 17, 2015

    Report

    Report Number
    2520274-2015-11873
    Event Type
    Injury
    Date Received
    March 17, 2015
    Report Date
    February 25, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LUITES, J.W.H., BRINKMAN, J.M., WYMENGA, A.B., VAN HEERWAARDEN, R. J (2009) FIXATION STABILITY OF OPENING- VERSUS CLOSING- WEDGE HIGH TIBIAL OSTEOTOMY. J BONE JOINT SURG [BR] 91-B: 1459-65. THIS REPORT IS FOR AN UNKNOWN TOMOFIX 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LUITES, J.W.H., BRINKMAN, J.M., WYMENGA, A.B., VAN HEERWAARDEN, R. J (2009) FIXATION STABILITY OF OPENING- VERSUS CLOSING- WEDGE HIGH TIBIAL OSTEOTOMY. J BONE JOINT SURG [BR] 91-B: 1459-65. BETWEEN DECEMBER 2001 AND AUGUST 2004, 42 PATIENTS (27 MEN, 15 WOMEN; MEAN AGE 42 YEARS; RANGE 40 TO 68 YEARS), A TOTAL OF 23 PATIENTS UNDERWENT OPEN WEDGE (OW)- HIGH TIBIAL OSTEOTOMY (HTO )(GROUP 1) AND 19 CLOSED WEDGE (CW)-HTO (GROUP 2). ANGLE-STABLE FIXATION WAS OBTAINED USING LATERAL OR MEDIAL TOMOFIX PLATES AND SCREWS (SYNTHES (B)(4)). IN NINE PATIENTS, AN INTRAOPERATIVE FRACTURE OF THE OPPOSITE TIBIAL CORTEX WAS DIAGNOSED ON POST-OPERATIVE RADIOGRAPHS, ONE IN GROUP 1 AND EIGHT IN GROUP 2. 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
    182388 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention