BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3883102 · Received June 19, 2014

    Report

    Report Number
    2520274-2014-11972
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. T. SAITO, T., KUMAGAI, K., AKAMATSU, Y., KOBAYASHI, H., AND KUSAYAMA, Y. (2014, MARCH). FIVE- TO TEN-YEAR OUTCOME FOLLOWING MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH RIGID PLATE FIXATION IN COMBINATION WITH AN ARTIFICIAL BONE SUBSTITUTE. BONE JOINT J, 96-B, 339¿44. THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM. 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, T. SAITO, T., KUMAGAI, K., AKAMATSU, Y., KOBAYASHI, H., AND KUSAYAMA, Y. (2014, MARCH). FIVE- TO TEN-YEAR OUTCOME FOLLOWING MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY WITH RIGID PLATE FIXATION IN COMBINATION WITH AN ARTIFICIAL BONE SUBSTITUTE. BONE JOINT J, 96-B, 339¿44. THE AUTHORS CONDUCTED A RETROSPECTIVE REVIEW OF CONSECUTIVE PATIENTS WITH EITHER MEDIAL COMPARTMENTAL OSTEOARTHRITIS (OA) - 65 KNEES IN 45 PATIENTS - OR SPONTANEOUS OSTEONECROSIS OF THE KNEE - 34 KNEES IN 34 PATIENTS - WHO UNDERWENT MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY BETWEEN 2003 AND 2007 WITH STABLE PLATE FIXATION, SYNTHES DEVICE TOMOFIX PLATE AND SCREWS AND AN ARTIFICIAL BONE SUBSTITUTE. OF THE INITIAL 77 PATIENTS (59 WOMEN, 18 MEN; MEDIAN AGE 69 YEARS), AFTER EXCLUSIONS THERE WERE 20 MEN AND 44 WOMEN (78 KNEES) AVAILABLE FOR REVIEW AT A MINIMUM OF FIVE YEARS. THE MEAN LENGTH OF FOLLOW-UP WAS 6.5 YEARS (FIVE TO TEN YEARS). ONE PATIENT WITH PERSISTENT SYMPTOMS AND UNDER-CORRECTION OF A VARUS DEFORMITY UNDERWENT UNICOMPARTMENTAL ARTHROPLASTY TWO YEARS POST-OPERATIVELY. THERE WAS ONE CASE OF DELAYED UNION, ONE OF INTRA-ARTICULAR FRACTURE OF THE LATERAL TIBIAL PLATEAU, AND ONE OF FRACTURE OF THE LATERAL TIBIAL CORTEX; THERE WERE NO CASES THAT REQUIRED ADDITIONAL SURGICAL TREATMENT. THIS IS A REPORTABLE MALFUNCTION REPORT INVOLVING ONE CASE OF DELAYED UNION; ADDITIONAL SURGICAL TREATMENT WAS NOT REQUIRED. THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360200 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1