BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: TOMOFIX OSTEOTOMY

    MDR report key: 10450013 · Received August 25, 2020

    Report

    Report Number
    8030965-2020-06296
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    July 30, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. THIS REPORT IS FOR AN UNKNOWN TOMOFIX OSTEOTOMY PLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN JANUARY 2010 AND FEBRUARY 2018. 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. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: MOON H., ET AL (2019)THE EFFECT OF MEDIAL OPEN WEDGE HIGH TIBIAL OSTEOTOMY ON THE PATELLOFEMORAL JOINT: COMPARATIVE ANALYSIS ACCORDING TO THE PREEXISTING CARTILAGE STATUS, BMC MUSCULOSKELETAL DISORDERS VOLUME 20, PAGES 607-611 (KOREA, SOUTH) HTTPS://DOI.ORG/10.1186/S12891-019-2989-Y THIS RETROSPECTIVE STUDY AIMS TO INVESTIGATE THE EFFECT OF MOWHTO ON THE PATELLOFEMORAL JOINT WITH REGARD TO THE OBJECTIVE AND SUBJECTIVE ASPECTS ACCORDING TO THE PREEXISTING CARTILAGE STATUS. BETWEEN JANUARY 2010 AND FEBRUARY 2018, 178 CONSECUTIVE PATIENTS, WHO UNDERWENT BIPLANE MOWHTO WERE REVIEWED RETROSPECTIVELY. A TOTAL OF 92 CASES WHO MET CRITERIA WERE INCLUDED IN THIS STUDY AND DIVIDED INTO 2 GROUPS ACCORDING TO THE PREEXISTING CARTILAGE STATUS OF THE PATELLOFEMORAL JOINT. THE DISTRIBUTION OF PATIENTS WAS AS FOLLOWS: (1) GROUP 1, 59 PATIENTS (16 MALES, 43 FEMALES) AGE 54.3 ± 5.2 YEARS WITH PATELLOFEMORAL JOINT CARTILAGE LESION GREATER THAN ICRS GRADE 2 AND (2) GROUP 2, 33 PATIENTS (10 MALES, 23 FEMALES) AGE 55.5 ± 4.4 YEARS WITH CARTILAGE LESION OF ICRS GRADE 0 OR 1. FIXATION WAS DONE USING TOMOFIX PLATE (SYNTHES, WEST CHESTER, PA). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: PATIENT OF GROUP 2 WITHOUT ANY PREEXISTING CARTILAGE LESIONS ON PATELLOFEMORAL JOINT SHOWED DEVELOPMENT OF CARTILAGE LESIONS AT SECOND-LOOK OPERATION. ASSESSMENT OF RADIOGRAPHIC OSTEOARTHRITIS GRADE OF PATELLOFEMORAL JOINT ACCORDING TO IWANO¿S CLASSIFICATION SYSTEM AT SECOND-LOOK OPERATION (POSTOPERATIVE):IN GROUP 1: 25 PATIENTS WITH STAGE 1 ,AND 26 PATIENTS WITH STAGE 2. IN GROUP 2: 13 PATIENTS WITH STAGE 1, AND 10 PATIENTS WITH STAGE 2. 10 PATIENTS IN GROUP 1 AND 10 PATIENTS IN GROUP 2 CARTILAGE LESION IN PATELLOFEMORAL COMPARTMENT PROGRESSED AT SECONDLOOK OPERATION. 32 PATIENTS (STAGE B)PARTIAL COVERAGE AND 9 PATIENTS (STAGE C)TOTAL COVERAGE IN GROUP 1 CARTILAGE LESION IN MEDIAL COMPARTMENT AT SECONDLOOK OPERATION. WHILE 18 PATIENTS (STAGE B)PARTIAL COVERAGE AND 7 PATIENTS (STAGE C)TOTAL COVERAGE IN GROUP 2 CARTILAGE LESION IN MEDIAL COMPARTMENT AT SECONDLOOK OPERATION. THIS REPORT IS FOR AN UNKNOWN SYNTHES TOMOFIX PLATE. THIS REPORT IS FOR ONE (1) UNKNOWN TOMOFIX OSTEOTOMY PLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914097 UNK - PLATES: TOMOFIX OSTEOTOMY PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention