BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: PLATE/SCREWS

    MDR report key: 10447801 · Received August 25, 2020

    Report

    Report Number
    8030965-2020-06264
    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
    KS
    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: HAN, S.-B. ET AL. (2019), COMPLICATIONS ASSOCIATED WITH MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY USING A LOCKING PLATE: A MULTICENTER STUDY, THE JOURNAL OF ARTHROPLASTY, VOL. 34 (3), PAGES 439-445 (KOREA, SOUTH). THE AIM OF THIS RETROSPECTIVE STUDY IS TO INVESTIGATE COMPLICATIONS FOLLOWING MEDIAL OWHTO USING A LOCKING PLATE BY MEANS OF A MULTICENTER STUDY. IN ADDITION, WE AIMED TO COMPARE POSTOPERATIVE OUTCOMES BETWEEN THE COMPLICATED GROUP AND THE UNCOMPLICATED GROUP. BETWEEN JUNE 2010 TO DECEMBER 2015, A TOTAL OF 209 PATIENTS (29 MALE AND 180 FEMALE) WITH A MEAN AGE OF 56.4 ± 5.9 YEARS (RANGE 27-65) UNDERWENT MEDIAL OPENING-WEDGE HIGH TIBIAL OSTEOTOMY (OWHTO). SURGERY WAS PERFORMED USING A FIXED-ANGLE PLATE WITH LOCKING SCREWS (TOMOFIX PLATE; DEPUY SYNTHES, WEST CHESTER, PA). THE FOLLOW-UP PERIOD WAS AT LEAST 2 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 10 PATIENTS HAD SYMPTOMATIC HARDWARE (HARDWARE IRRITATION) IN WHICH METAL REMOVAL WAS DONE AFTER UNION WAS ACHIEVED. 4 PATIENTS HAD DEEP WOUND INFECTION, RECEIVED IRRIGATION AND DEBRIDEMENT, HARDWARE REMOVAL, AND INTRAVENOUS ANTIBIOTICS. 2 PATIENTS HAD HARDWARE FAILURE WITH CORRECTION LOSS AND 1 PATIENT HAD NONUNION. REVISIONS WERE PERFORMED USING A LOCKING PLATE WITH AUTOGENOUS ILIAC BONE GRAFT. 1 PATIENT UNDERWENT CONVERSION TO ARTHROPLASTY AT POSTOPERATIVE 5 MONTHS. 25 PATIENTS HAD UNDISPLACED (<2 MM) LATERAL HINGE FRACTURE. 5 PATIENTS HAD DISPLACED (>2 MM) LATERAL HINGE FRACTURE. 4 PATIENTS HAD DELAYED WOUND HEALING. 2 PATIENTS HAD UNDISPLACED (<2 MM) LATERAL TIBIAL PLATEAU FRACTURE. 2 PATIENTS HAD SUPERFICIAL WOUND INFECTION. 3 PATIENTS HAD HARDWARE IRRITATION. 1 PATIENT HAD COMPLEX REGIONAL PAIN SYNDROME TYPE 1. 2 PATIENTS HAD CELLULITIS. 1 PATIENT HAD SPONTANEOUS OSTEONECROSIS OF THE KNEE. AMONG ALL COMPLICATIONS, MOST OF THE COMPLICATIONS (70.9%) OCCURRED INTRAOPERATIVELY (30.6%) OR WITHIN 3 MONTHS POSTOPERATIVELY (40.3%). AMONG THE 30 CASES OF UNDISPLACED AND DISPLACED LATERAL HINGE FRACTURES, 13 CASES SHOWED DELAYED LATERAL HINGE FRACTURE, WHICH WAS NOT IDENTIFIED INTRAOPERATIVELY BUT IDENTIFIED AT 3 OR 6 MONTHS POSTOPERATIVELY. THIS REPORT IS FOR AN UNKNOWN SYNTHES PLATE/ SCREWS CONSTRUCTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913043 UNK - CONSTRUCTS: PLATE/SCREWS PLATE, FIXATION ,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention