BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES

    MDR report key: 9526186 · Received December 27, 2019

    Report

    Report Number
    1526439-2019-52791
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    August 15, 2017
    Report Date
    December 3, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). 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: WEI, X.Z. ET AL (2017), KEY VERTEBRAL PEDICLE SCREW STRATEGY FOR THE CORRECTION OF FLEXIBLE LENKE TYPE 1 ADOLESCENT IDIOPATHIC SCOLIOSIS. A PRELIMINARY STUDY OF A 5-YEAR MINIMUM RADIOGRAPHIC FOLLOW-UP, SPINE, VOL. 42 (16), PAGES 1226-1232, DOI: 10.1097/BRS.0000000000002143 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO DETERMINE THE LONG-TERM RESULTS OF POSTERIOR CORRECTION AND FUSION WITH PEDICLE SCREW FIXATION USING THIS TREATMENT STRATEGY. BETWEEN JANUARY 2008 TO MARCH 2015, A TOTAL OF 20 PATIENTS (2 MALE AND 18 FEMALE) WITH AN AVERAGE AGE OF 14.7±1.7 YEARS (RANGE: 11.0¿18.0 YEARS) UNDERWENT ONE-STAGE POSTERIOR CORRECTION AND FUSION. SURGERY WAS PERFORMED USING EXPEDIUM (UNIAXIAL PEDICLE SCREW) IN 14 PATIENTS AND MOSS-MIAMI (DEPUY SPINE INC.) INSTRUMENTATION SYSTEMS IN 6 PATIENTS. THE AVERAGE LENGTH OF FOLLOW-UP WAS 64.1±3.8 MONTHS (RANGE: 62.0¿72.0 MONTHS). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: THE CORONAL COBB ANGLE OF THE MT CURVE CHANGED FROM 15.88±3.18 TO 17.48±3.48 REPRESENTING A 3.6% LOSS OF CORRECTION. THE PROGRESSION IN THE TL/L CURVE WAS SIGNIFICANT, WITH A CHANGE FROM 12.78±3.78 TO 14.08±3.48, REPRESENTING A 5.3% LOSS OF CORRECTION. 1 PATIENT EXPERIENCED A WOUND INFECTION 1 WEEK AFTER SURGERY THAT WAS RESOLVED BY COMPREHENSIVE DEBRIDEMENT AND ANTIBIOTIC THERAPY. 2 PATIENTS HAD MILD JUNCTIONAL KYPHOSIS. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE SCREW/ROD CONSTRUCT (EXPEDIUM AND MOSS-MIAMI). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318255 UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIES ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention