BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CONCORDE CAGE

    MDR report key: 12093508 · Received June 30, 2021

    Report

    Report Number
    1526439-2021-01342
    Event Type
    Injury
    Date Received
    June 30, 2021
    Report Date
    June 8, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MQP
    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 CONCORDE CAGE/UNKNOWN LOT. PART AND LOT NUMBER 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: KALININ A.A., ET AL (2019) ANALYSIS OF THE RESULTS OF FOUR YEARS OF TREATMENT OF NERVE ROOT IMPRINGEMENT IN THE CERVICAL SPINE WITH DISCECTOMY AND ANTERIOR SPINAL FUSION, SIBERIAN MEDICAL JOURNAL (IRKUTSK), NO. 2, PAGES 1-8 (RUSSIA). THIS STUDY AIMS TO ANALYZE THE RESULTS OF FOUR YEARS OF SURGICAL TREATMENT OF SURGICAL NRI BY DISCECTOMY AND ANTERIOR SPINAL FUSION. DURING THE PERIOD 2012-2018, 105 PATIENTS (55 MEN, 50 WOMEN) AGED 27 TO 55 YEARS (MEAN AGE 38.1 YEARS) WITH COMPRESSION OF THE SPINAL CORD AND/OR ROOT BY DISC OSTEOPHYTE COMPLEXES WHO, AFTER VERIFICATION OF CLINICALLY SIGNIFICANT NRI, UNDERWENT A MICROSURGICAL DISCECTOMY WITH THE INSTALLATION OF AN HRC CERVICAL (ZIMMER, USA) / CONCORDE (DEPUY SYNTHES, SWITZERLAND) / PCB EVOLUTION (SCIENT¿X, FRANCE) CAGE AT THE NEUROSURGERY CENTER AT THE NON-GOVERNMENTAL HEALTHCARE FACILITY, RAILROAD CLINICAL HOSPITAL (DKB) AT IRKUTSK-PASSAZHIRSKY STATION OF OAO RZHD WERE INCLUDED IN THE STUDY. THE DYNAMIC EVALUATION WAS MADE IN THE PERIOD FROM 36 MONTHS TO 60 MONTHS (MEDIAN 48 MONTHS) AFTER SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED: AN OBJECTIVE ASSESSMENT ON THE NURICK SCALE AN AVERAGE OF 48 MONTHS AFTER SURGERY SHOWED: 55 EXPERIENCED COMPLETE REGRESSION OF NEUROLOGICAL SYMPTOMS. AN ANALYSIS OF NEUROLOGICAL STATUS OVERTIME AT THE STUDY PROTOCOL INTERVALS (3, 6, 12, AND 24, 36, 48 MONTHS AFTER SURGERY) SHOWED PERSISTENT REGRESSION OF SENSORY AND MOTOR DEFICIENCY. 6 PATIENTS HAD SIGNS OF ASYMPTOMATIC DEGENERATION OF SUPERJACENT CERVICAL SEGMENTS, AND 2 ¿ OF SUBJACENT SEGMENTS, AND THE ADDITIONAL SURGICAL CORRECTION WAS NOT NEEDED. SUPERFICIAL INFECTION OF THE SURGICAL INTERVENTION AREA OCCURRED IN 3 CASES. THERE WERE 2 CASES OF THE FORMATION OF AN INTERMUSCULAR HEMATOMA AFTER BI-LEVEL ACDF. IN ALL CASES, CONSERVATIVE INTERVENTION ELIMINATED THE COMPLICATIONS WITHOUT EXTENDING INPATIENT TREATMENT. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE CONCORDE CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991131 UNK CONCORDE CAGE SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention