BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9565857 · Received January 8, 2020

    Report

    Report Number
    1526439-2020-00297
    Event Type
    Injury
    Date Received
    January 8, 2020
    Report Date
    December 12, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAILABLE FOR EVALUATION: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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: KIM, Y. ET AL. (2005), PROXIMAL JUNCTIONAL KYPHOSIS IN ADOLESCENT IDIOPATHIC SCOLIOSIS FOLLOWING SEGMENTAL POSTERIOR SPINAL INSTRUMENTATION AND FUSION, SPINE, VOL. 30, NUMBER 18, PAGES 2045-2050 (USA). THE PURPOSE OF THIS STUDY IS TO ANALYZE THE LONG-TERM PROXIMAL JUNCTIONAL CHANGE IN ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS) FOLLOWING SEGMENTAL POSTERIOR SPINAL INSTRUMENTATION AND FUSION 5 YEARS OR MORE AFTER SURGERY. A TOTAL OF 193 PATIENTS (27 MALES AND 166 FEMALES) WITH AN AVERAGE AGE OF 14.3 YEARS (RANGE, 10.8¿19.4 YEARS) UNDERWENT SEGMENTAL POSTERIOR SPINAL INSTRUMENTATION AND FUSION USING A 5.0-MM MOSS-MIAMI (DEPUY ACROMED, RAYNHAM, MA) INSTRUMENTATION. THERE WAS A 5-YEAR MINIMUM FOLLOW-UP (AVERAGE, 7.3 YEARS; RANGE, 5¿16.7 YEARS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: A (B)(6) YEAR OLD FEMALE PATIENT HAD A 51% CORRECTION RATE. 50 PATIENTS HAD PROXIMAL JUNCTIONAL KYPHOSIS (7.3 YEARS POSTOPERATION). AMONG THEM, 41 PATIENTS DEMONSTRATED PJK AT 2-YEAR POSTOPERATION. 9 PATIENTS WHO DID NOT SHOW PJK AT 2-YEAR POSTOPERATION DEMONSTRATED PJK AT FINAL FOLLOW-UP BETWEEN 10 DEGREES AND 14 DEGREES. PATIENTS WHO SHOWS PJK DEMONSTRATED SIGNIFICANT ANTERIOR DISPLACEMENT OF THE C5 SAGITTAL PLUMB. THIS REPORT IS FOR A 5.0-MM MOSS-MIAMI (DEPUY ACROMED, RAYNHAM, MA) INSTRUMENTATION. THIS COMPLAINT INVOLVES TWO (2) DEVICE. THIS IS 2 OF 2 FOR REPORT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27152 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention