BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPENSOR, CEMENT

    MDR report key: 3983189 · Received August 6, 2014

    Report

    Report Number
    1526439-2014-11727
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    August 8, 2013
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THIS REPORT IS FOR UNK-SPINE (CEMENT). CEMENT UNKNOWN PART/OT NUMBERS. INVESTIGATION COULD NOT BR COMPLETED AND NO CONCLUSION COULD BR DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RADIOGRAPHIC AND SAFETY DETAILS OF VERTEBRAL BODY STENTING: RESULTS FROM A MULTICENTER CHART REVIEW. DIET ET AL. (2013) BMC MUSCULOSKELETAL DISORDERS 14:233. THIS WAS A OBSERVATIONAL STUDY WHERE DATA WAS COLLECTED RETROSPECTIVELY FROM A MULTICENTER CHART REVIEW OF THE FIRST 100 CASES OF PATIENTS WITH VERTEBRAL BODY FRACTURES WHO WERE TREATED WITH THE VERTEBRAL BODY STENTING SYSTEM (VBS). THE AIM OF THE ANALYSIS WAS TO DESCRIBE THE CLINICAL AND RADIOGRAPHIC RESULTS OF THE NEW ENDOVERTEBRAL STENTING SYSTEM. THE VBS SYSTEM USED IN THE STUDY WAS MANUFACTURED BY SYNTHES GMBH, OBERDORF, SWITZERLAND. ONE HUNDRED (100) PATIENTS (62 WITH OSTEOPOROSIS) WITH A TOTAL OF 103 VERTEBRAL BODY FRACTURES WERE TREATED WITH THE VBS SYSTEM. THE STUDY POPULATION CONSISTED OF 49 FEMALES WITH A MEAN AGE OF 71 YEARS AND 51 MALES WITH A MEAN AGE OF 67 YEARS. IN 55% OF CASES SYNTHES' VERTECEM "NF"PMMA-BASED CEMENT AND IN 45% OTHER PMMA-BASED CEMENTS WERE APPLIED. AT THE LAST RADIOGRAPHIC FOLLOW-UP (APPROXIMATELY 6 MONTHS) VISIT THERE WAS AN IMPROVEMENT IN THE MEAN ANTERIOR-MIDDLE-POSTERIOR HEIGHTS POSTOPERATIVELY COMPARED TO THE PREOPERATIVE MEASUREMENTS. THERE WERE NO IDENTIFIABLE PATIENTS. THIS ARTICLE REQUIRES (4) MEDWATCHS: UNK-SPINE (VBS) RM. UNK-SPINE (VBS) SI. UNK-SPINE (CEMENT) RM. UNK-SPINE (CEMENT) SI. THIS LITERATURE ARTICLE IS ATTACHED TO THIS MEDWATCH. THIS MEDWATCH IS FOR THE (B)(4) CEMENT EXTRUSIONS. THIS IS REPORT 2 OF 4 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461876 DISPENSOR, CEMENT KIH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention