BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, RIB REPLACEMENT

    MDR report key: 8691706 · Received June 12, 2019

    Report

    Report Number
    2939274-2019-58602
    Event Type
    Injury
    Date Received
    June 12, 2019
    Report Date
    May 15, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    MDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN VEPTR/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: JOUKHADAR, N. ET AL. (2018), SUPERIOR EXTENSION OF UPPER INSTRUMENTED VERTEBRAE IN DISTRACTION-BASED SURGERY: A SURROGATE FOR CLINICALLY SIGNIFICANT PROXIMAL JUNCTIONAL KYPHOSIS, SPINE DEFORMITY, VOL. 7, PAGES 371-375 (CANADA). THE PRIMARY PURPOSE OF THIS STUDY WAS TO DETERMINE THE RISK OF CLINICALLY SIGNIFICANT PROXIMAL JUNCTIONAL KYPHOSIS (PJK) DURING DISTRACTION-BASED GROWTH FRIENDLY SURGERY. THE SECONDARY GOAL WAS TO COMPARE THE RISK OF DEVELOPING CLINICAL PJK BETWEEN PROXIMAL RIB-BASED AND PROXIMAL SPINE-BASED DISTRACTION SURGERY. A TOTAL OF 218 PATIENTS WITH A MEAN PREOPERATIVE AGE OF 5.2 YEARS HAD BEEN TREATED WITH RIB-BASED PROXIMAL ANCHORS USING AN UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR). THE MINIMUM FOLLOW-UP WAS 2 YEARS AND THERE WAS A MINIMUM OF 3 LENGTHENING PROCEDURES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 218 PATIENTS DEVELOPED PJK BECAUSE OF THE TREATMENT OF RIB-BASED PROXIMAL ANCHORS USING VEPTR. 52 PATIENTS REQUIRED PROXIMAL EXTENSION OF THE UPPER INSTRUMENT VERTEBRAE (UIV) FOR AN OVERALL RISK OF CLINICALLY SIGNIFICANT PJK OF 20 PERCENT. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS IS FOR AN UNKNOWN SYNTHES VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484119 PROSTHESIS, RIB REPLACEMENT MDI WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention