BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SYNFLATE/VBS

    MDR report key: 9221487 · Received October 22, 2019

    Report

    Report Number
    8030965-2019-69533
    Event Type
    Injury
    Date Received
    October 22, 2019
    Report Date
    September 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 510K: THIS REPORT IS FOR AN UNKNOWN SYNTHES SYNFLATE DEVICE. 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WINKELMANN, M. ET AL (2018), RADIOLOGICAL AND CLINICAL OUTCOMES OF BALLOON KYPHOPLASTY VERSUS RADIOFREQUENCY KYPHOPLASTY IN THE TREATMENT OF VERTEBRAL COMPRESSION FRACTURES, ASIAN SPINE JOURNAL, VOL. 12 (5), PAGES 862-869 (GERMANY). THE AIM OF THIS RETROSPECTIVE COHORT STUDY IS TO INVESTIGATE WHETHER BKP AND RFK CAN RESTORE VERTEBRAL BODY HEIGHT AND ARE SUITABLE FOR PAIN RELIEF IN VERTEBRAL COMPRESSION FRACTURES. FURTHER, THIS STUDY ADDRESSES IF THERE IS ANY DIFFERENCE IN THE CLINICAL AND RADIOLOGICAL OUTCOMES BETWEEN BKP AND RFK AND WHETHER THERE IS A CORRELATION BETWEEN HEIGHT RESTORATION AND PAIN RELIEF. BETWEEN JANUARY 2005 TO DECEMBER 2014, A TOTAL OF 156 PATIENTS (51 MALE AND 105 FEMALE) WITH A MEAN AGE OF 79±11 YEARS, WITH 252 FRACTURED VERTEBRAL BODIES WERE TREATED WITH KYPHOPLASTY. THE PATIENTS WERE DIVIDED ACCORDING TO THE APPROACH PERFORMED. BALLOON KYPHOPLASTY (BKP) GROUP CONSIST OF 135 PATIENTS AND WERE IMPLANTED WITH SYNFLATE (DEPUY SYNTHES, WEST CHESTER, PA, USA) SYSTEM OR A COMPETITOR'S DEVICE, WHILE RADIOFREQUENCY KYPHOPLASTY (RFK) GROUP CONSIST OF 21 PATIENTS AND WERE IMPLANTED WITH A COMPETITOR'S DEVICE. THE PATIENTS HAD THREE FOLLOW-UP SESSIONS: IMMEDIATELY AFTER OPERATION, AT 6 WEEKS AFTER OPERATION, AND AT 1 YEAR AFTER OPERATION. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: AT THE 6-WEEK FOLLOW-UP, THERE WAS A SIGNIFICANT LOSS OF REDUCTION IN THE BISEGMENTAL COBB ANGLE (1.3°±4.6°, P=0.002) AND HA VERTEBRAL BODY HEIGHT (HA, -0.9±3.0 MM; P<0.001). AT THE 1-YEAR FOLLOW-UP, A FURTHER SLIGHT LOSS OF REDUCTION PRIMARILY AT THE ANTERIOR VERTEBRAL BODY EDGE (HA, -0.9±2.2 MM; P=0.04; HM, -0.8±1.6 MM; P=0.01). THIS REPORT IS FOR AN UNKNOWN SYNTHES SYNFLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015842 UNK - SYNFLATE/VBS POLYMETHYLMETHACRYLATE BONE CEMENT NDN OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention