BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4608935 · Received March 17, 2015

    Report

    Report Number
    2520274-2015-11815
    Event Type
    Injury
    Date Received
    March 17, 2015
    Date of Event
    October 10, 2014
    Report Date
    February 25, 2015
    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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BODE, G. ET AL "CLINICAL OUTCOME AND RETURN TO WORK FOLLOWING SINGLE-STAGE COMBINED AUTOLOGOUS CHONDROCYTE IMPLANTATION AND HIGH TIBIAL OSTEOTOMY". INTERNATIONAL ORTHOPAEDICS. DOI 10.1007/S00264-014-2547-Z. HIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE REVIEW BODE, G. ET AL "CLINICAL OUTCOME AND RETURN TO WORK FOLLOWING SINGLE-STAGE COMBINED AUTOLOGOUS CHONDROCYTE IMPLANTATION AND HIGH TIBIAL OSTEOTOMY". INTERNATIONAL ORTHOPAEDICS. DOI 10.1007/S00264-014-2547-Z. THIS WAS A RETROSPECTIVE STUDY OF FORTY PATIENTS WITH FULL-THICKNESS CARTILAGE DEFECTS OF THE MEDICAL FEMORAL CONDYLE (MFC) GRADE III OR IV AND A MINIMUM VALGUS DEFORMITY OF 2 DEGREES. PATIENTS WERE TREATED WITH A COMBINED SINGLE STAGE AUTOLOGOUS CHONDROCYTE IMPLANTATION (ACI) AND HIGH TIBIAL OSTEOTOMY (HTO) BETWEEN JANUARY 2004 AND DECEMBER 2010. THE TOMOFIX SYSTEM WAS USED TO STABILIZE THE OSTEOTOMY. FOUR PATIENTS REQUIRED REVISION SURGERY. TWO PATIENTS HAD PERSISTING PAIN AND FAILURE OF THE ACI. ONE PATIENT HAD OVERCORRECTION WITH POSTOPERATIVE VALGIZATION >70% OF THE TIBIAL PLATEAU, AND ONE PATIENT HAD A NONUNION OF THE OSTEOTOMY GAP. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN TOMOFIX SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180943 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention