BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10447887 · Received August 25, 2020

    Report

    Report Number
    8030965-2020-06266
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    July 29, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: 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. (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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YOKOYAMA, M. ET AL (2019), STRESS FRACTURES OF THE LATERAL TIBIAL PLATEAU AFTER OPEN WEDGE HIGH TIBIAL OSTEOTOMY COULD BE DELAYED TYPE III LATERAL HINGE FRACTURES, ASIA-PACIFIC JOURNAL OF SPORTS MEDICINE, ARTHROSCOPY, REHABILITATION AND TECHNOLOGY, VOL. 18 (XX), PAGES 23-27 (JAPAN). THE AIM OF THIS RETROSPECTIVE STUDY IS TO EXAMINE THE CONDITIONS AND TRIGGERS OF SUCH FRACTURES UNDER OUR HYPOTHESIS THAT IT IS A STRESS FRACTURE OF THE LTP AND A DELAYED TYPE III LHF. BETWEEN 2012 AND 2015, A TOTAL OF 118 PATIENTS (44 MALE AND 74 FEMALE) WITH A MEAN AGE OF 64 YEARS (RANGE, 40-72 YEARS) UNDERWENT OPEN WEDGE HIGH TIBIAL OSTEOTOMY (OWHTO). SURGERY WAS PERFORMED USING A LOCKING PLATE (TOMOFIX®). PATIENTS WERE DIVIDED INTO THE STRESS FRACTURE GROUP (GROUP SF) IF THEY SHOWED FRACTURE LINES ON CT PERFORMED AFTER STARTING WEIGHT-BEARING WALKING AND FOR OTHERS IN THE NORMAL GROUP (GROUP N). THE MEAN FOLLOW-UP DURATION WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 12 PATIENTS DEVELOPED PAIN AT THE OUTSIDE OF THE KNEE JOINT IN THE FOLLOW-UP TRAINING, AND CT SHOWED A SMALL FRACTURE OF THE LTP NOT OBSERVED ON THE DAY AFTER SURGERY. THESE CASES WERE DIAGNOSED AS STRESS FRACTURES OF THE LTP (FIG. 2). WE DEFINED DELAYED TYPE III FRACTURES AS FOLLOWS. THE FRACTURE CANNOT BE CONFIRMED ON CT SCAN RIGHT AFTER OWHTO AND DURING THE NON-WEIGHT BEARING WALKING, BUT A FRACTURE RESEMBLING TAKEUCHI¿S TYPE II LATERAL HINGE FRACTURE AFTER THE START OF WEIGHT BEARING WALKING HAS BEEN CONFIRMED IN LTP. IN 52 PATIENTS, A LATERAL HINGE FRACTURE WAS DETECTED, AND THEY WERE CLASSIFIED INTO 3 TYPES ACCORDING TO THE TAKEUCHI CLASSIFICATION: 41 CASES OF TYPE I; 2 CASES OF TYPE II; AND 9 CASES OF TYPE III. LHFS OCCURRED IN 44 CASES UNDER GROUP N AND 8 CASES UNDER GROUP SF. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATE/SCREWS CONSTRUCTS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915555 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention