BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

    MDR report key: 8659013 · Received May 31, 2019

    Report

    Report Number
    8030965-2019-64741
    Event Type
    Injury
    Date Received
    May 31, 2019
    Report Date
    May 2, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TOTAL OF 23 PATIENTS (8 MALES AND 15 FEMALES) WITH A MEAN AGE OF 48 YEARS (RANGE, 31 - 65 YEARS) WERE INCLUDED IN THE STUDY. THIS REPORT IS FOR AN UNKNOWN SYNTHES UNIVERSAL SPINE SYSTEM/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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ZHANG SHIMIN ET. AL (2003), TREATMENT OF LUMBAR SPONDYLOLISTHESIS WITH UNIVERSAL SPINE SYSTEM, CHINESE JOURNAL OF ORTHOPAEDIC TRAUMA VOL. 16(11), PAGES 1-4 (CHINA). THE AIM OF THIS ARTICLE IS TO IMPACT OF THE TREATMENT OF LUMBAR SPONDYLOLISTHESIS WITH UNIVERSAL SPINE SYSTEM. BETWEEN MAY 2000 TO JANUARY 2003, A TOTAL OF 23 PATIENTS (8 MALES AND 15 FEMALES) WITH A MEAN AGE OF 48 YEARS (RANGE, 31 - 65 YEARS) WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD LUMBAR SPINAL STENOSIS AND UNDERWENT SPINAL CANAL DECOMPRESSION AND INTERTRANSVERSE PROCESS BONE GRAFT FUSION AND UNIVERSAL SPINE SYSTEM (USS). THE MEAN DURATION OF FOLLOW-UP WAS 19.5 MONTHS (RANGES 3 ¿ 32 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT DEVELOPED NERVE ROOT TRACTION SYMPTOMS AFTER SURGERY, WHICH DISAPPEARED AFTER 1 WEEK OF TREATMENT. THIS REPORT IS FOR A SYNTHES UNIVERSAL SPINE SYSTEM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452314 ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention