BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS

    MDR report key: 12548436 · Received September 29, 2021

    Report

    Report Number
    8030965-2021-08133
    Event Type
    Injury
    Date Received
    September 29, 2021
    Report Date
    August 31, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNK - 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: DORNACHER D, ET AL. (2021), THE DEGREE OF CORRECTION IN OPEN-WEDGE HIGH TIBIAL OSTEOTOMY COMPROMISES BONE HEALING: A CONSECUTIVE REVIEW OF 101 CASES, THE KNEE, VOLUME 29, PAGES 478-485. (GERMANY) THE AIM OF THIS EXAMINATION WAS TO ANALYSE THE RISK FACTORS LEADING TO A DISTURBANCE IN BONE HEALING IN OUR PATIENT POPULATION TREATED WITH AN OPEN-WEDGE HIGH TIBIAL OSTEOTOMY DUE TO EARLY-STAGE UNICOMPARTMENTAL VARUS OSTEOARTHRITIS. BETWEEN 2011 AND 2017, 96 PATIENTS (101 CASES) WHO UNDERWENT AN OPEN-WEDGE HIGH TIBIAL OSTEOTOMY WERE INCLUDED IN THE STUDY. THERE WERE 27 FEMALES AND 69 MALES WITH A MEAN AGE OF 41.4 YEARS (RANGE, 17-64 YEARS). AFTER OSTEOTOMY, ALL TIBIAE WERE STABILIZED WITH AN UNKNOWN SYNTHES TOMOFIX LOCKING PLATE SYSTEM. THE MOBILIZATION OF THE PATIENT STARTED AT THE FIRST POSTOPERATIVE DAY. PATIENTS WERE ALLOWED TO HAVE PARTIAL WEIGHT BEARING FOR THE FIRST 6 WEEKS AFTER THE OSTEOTOMY. INDEPENDENT OF THE ADDITIONALLY PERFORMED PROCEDURES, INPATIENT REHABILITATION WAS OFFERED TO EVERY PATIENT, STARTING RIGHT AFTER THE FOLLOW UP EXAMINATION 6 WEEKS POSTOPERATIVELY. DURING THIS 3-WEEK REHABILITATION PROTOCOL, FULL WEIGHT BEARING WAS ACHIEVED. THE CLINICAL AND RADIOGRAPHIC FOLLOW UP WAS PERFORMED 3¿5 DAYS AFTER THE INTERVENTION AND CONTINUED AT 6 WEEKS POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: A TOTAL OF 16 PATIENTS HAD DISTURBED BONE HEALING. 11 PATIENTS HAD 2 OF THE 3 CORTICALICES WERE NOT HEALED AT 18 MONTHS AFTER THE SURGERY. THE REMOVAL OF THE LOCKING PLATE WAS SCHEDULED ABOUT 2 YEARS AFTER THE OSTEOTOMY. NO MECHANICAL ISSUES OCCURRED IN ANY OF THE PATIENTS AFTER THE REMOVAL OF THE FIXATION DEVICE. 5 PATIENTS HAD NONE OF THE 3 CORTICALICES HEALED AT 18 MONTHS AFTER THE SURGERY. THESE PATIENTS UNDERWENT REVISION SURGERY, THE GAP WAS FILLED WITH AUTOGENOUS CANCELLOUS BONE AND A MONO- OR TRICORTICAL BONE GRAFT FROM THE ILIAC CREST. A (B)(6) YEAR-OLD PATIENT HAD NO PROGRESS IN BONE HEALING AT 12 MONTHS POSTOPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY, THE GAP WAS FILLED WITH AUTOGENOUS CANCELLOUS BONE IN ADVANCE OF THE REMOVAL OF THE LOCKING PLATE. 10 PATIENTS HAD DISTURBANCE OF WOUND HEALING. 31 PATIENTS HAD LATERAL HINGE FRACTURES. THIS REPORT IS FOR THE UNKNOWN SYNTHES TOMOFIX LOCKING PLATE SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR ONE (1) UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446577 UNK - CONSTRUCTS: TOMOFIX PLATE/SCREWS PLATE, FIXATION, BONE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention