BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - STENOFIX

    MDR report key: 9907999 · Received March 31, 2020

    Report

    Report Number
    8030965-2020-02469
    Event Type
    Injury
    Date Received
    March 31, 2020
    Report Date
    March 5, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MNI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN STENOFIX/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BERSNEV, V.P., DRAGUN, V.M., MIKAILOV, S.YU., KUDZIEV, A.V. (2016), SURGICAL TREATMENT OF LUMBAR SPINAL STENOSIS WITH INTERSPINOUS IMPLANTABLE DEVICES, NEW MEDICAL TECHNOLOGIES (RUSSIA). THE AIM OF THIS RANDOMIZED STUDY IS TO SELECT OPTIMAL TACTICS FOR THE TREATMENT OF DEGENERATIVE-DYSTROPHIC DISEASES BASED ON CLINICAL EXAMINATION RESULTS AND CLINICAL SYMPTOMS. BETWEEN 2012 TO 2015, A TOTAL OF 114 PATIENTS (67 MALE AND 47 FEMALE) WERE INCLUDED IN THE STUDY, THESE PATIENTS WERE DIVIDED INTO TWO GROUPS AS A FUNCTION OF THE SURGICAL INTERVENTION PERFORMED: THE FIRST GROUP (GROUP A) HAS A TOTAL OF 56 PATIENTS, WITH AN AVERAGE AGE OF 47.2 ± 6.7 YEARS, UNDERWENT MICROSURGICAL DECOMPRESSION ON THE LUMBAR SPINE AND THE PLACEMENT OF INTERSPINOUS DYNAMIC DEVICES, WHILE THE COMPARISON GROUP (GROUP B) HAS A TOTAL OF 58 PATIENTS WITH AN AVERAGE AGE OF 44.4 ± 6.1 YEARS UNDERWENT MICROSURGICAL DECOMPRESSION WITHOUT THE USE OF IMPLANT DEVICES (N = 58). SURGERY WAS PERFORMED USING STENOFIX OR A COMPETITOR'S DEVICE. THE TREATMENT RESULTS WERE CAREFULLY ANALYZED OVER A PERIOD OF 6 MONTHS TO 2 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT HAD REPEATED SURGERY WHEN AN INTERSPINOUS DEVICE BROKE. 6 PATIENTS HAD SPACES BETWEEN THE IMPLANTED DEVICES AND THE SPINOUS PROCESSES. THIS REPORT IS FOR AN UNKNOWN SYNTHES STENOFIX. IT CAPTURES THE REPORTED SPACES BETWEEN THE IMPLANTED DEVICES AND THE SPINOUS PROCESSES. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366132 UNK - STENOFIX ORTHOSIS, PEDICLE SPINAL FIXATION MNI OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention