BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS

    MDR report key: 12671649 · Received October 21, 2021

    Report

    Report Number
    8030965-2021-08846
    Event Type
    Injury
    Date Received
    October 21, 2021
    Date of Event
    March 31, 2020
    Report Date
    September 23, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: TOMOFIX PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: FÜRMETZ, J. ET AL. (2020), TIBIAL AND FEMORAL OSTEOTOMIES IN VARUS DEFORMITIES - RADIOLOGICAL AND CLINICAL OUTCOME, BMC MUSCULOSKELETAL DISORDERS, VOL. 21(201), PAGES 1-8 (GERMANY). THIS STUDY EVALUATES RADIOLOGICAL AND CLINICAL OUTCOMES AFTER VALGISATION OSTEOTOMIES IN THE PROXIMAL TIBIA AND DISTAL FEMUR. FROM 2009 TO 2016, 28 PATIENTS WITH SYMPTOMATIC VARUS DEFORMITY WERE TREATED WITH DEFORMITY CORRECTION (MEDIAL TIBIAL OPENING (OHTO) OR LATERAL FEMORAL CLOSING (CDFO)) CLOSE TO THE KNEE JOINT. THERE WERE 18 MALES AND 10 FEMALES. THE IMPLANTS USED FOR OHTO WAS A TOMO-FIX (SYNTHES, OBERDORF, SWITZERLAND) PLATES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 OCCURRENCE OF DELAYED BONE FORMATION IN THE OHTO GROUP WAS SUCCESSFULLY TREATED WITH AUTOLOGOUS BONE GRAFTING. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1570742 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS APPLIANCE, FIXATION, NAIL KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention