BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPENSER, CEMENT

    MDR report key: 6774010 · Received August 8, 2017

    Report

    Report Number
    2520274-2017-12057
    Event Type
    Injury
    Date Received
    August 8, 2017
    Report Date
    July 26, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    KIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT FOR DIAGNOSIS. SCOLA, A; GEBHARD, F; SCHULTHEISS, M (2010) 5 DEUTSCHER WIRBELSAULENKONGRESS ABSTRACT ¿ ARTICLE P87; PRELIMINARY CLINICAL RESULTS WITH VERTEBRAL BODY STENTING. EUR SPINE J. 19:1963-2073. THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY STENTING (UNKNOWN QUANTITY/UNKNOWN LOT). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: SCOLA, A; GEBHARD, F; SCHULTHEISS, M (2010) 5 DEUTSCHER WIRBELSAULENKONGRESS ABSTRACT ¿ ARTICLE P87; PRELIMINARY CLINICAL RESULTS WITH VERTEBRAL BODY STENTING. EUR SPINE J. 19:1963-2073. THIS IS A RETROSPECTIVE BIOMECHANICAL STUDY TO SHOW AN ENHANCED REPOSITION OF THE FRACTURE COMPARED TO CONVENTIONAL KYPHOPLASTY. A TOTAL OF 57 VERTEBRAL BODIES (19 THORACAL, 38 LUMBAL, TH6 TILL L4) IN 53 PATIENTS (31 WOMEN, 22 MEN, AVERAGE AGE 76,2 ±8,9 YEARS) WERE OPERATED USING VERTEBRAL BODY STENTING VBS SYSTEM MANUFACTURED BY SYNTHES. FORTY-FIVE (45) PATIENTS HAD AN OSTEOPOROTIC AND 8 PATIENTS A PATHOLOGICAL FRACTURE. THE IMPLANTATION OF THE VERTEBRAL BODY STENT WAS POSSIBLE IN ALL CASES. THE AVERAGE HEIGHT GAIN IN THE MIDDLE OF THE VERTEBRAL BODY WAS 0.27 CM (SD±0.16), ANTERIOR 0.26 CM (SD±0.16). THE PERCENTAGE GAIN IN THE MIDDLE WAS 21% (SD±16.3), ANTERIOR 15,3% (SD±13,3). IN ONE CASE THE STENT COULD NOT BE DILATED ON ONE SIDE DUE TO A SCLEROTIC AREA. IN ANOTHER CASE THE LATERAL WALL OF THE VERTEBRAL BODY WAS FRACTURED WHILE DILATING THE STENT. THIS WAS NOT RECOGNIZED DURING THE OPERATION. THERE HAVE BEEN NO POSTOPERATIVE NEUROLOGIC PROBLEMS. THE RESULTS SHOW THAT USING THE VERTEBRAL BODY STENTING SYSTEM A GOOD FRACTURE REPOSITION CAN BE ACHIEVED. IT IS A SAVE SYSTEM WITH FEW COMPLICATIONS. THIS IS 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN VERTEBRAL BODY STENTING AND REFERS TO THE SERIOUS INJURY OF 1 UNKNOWN PATIENT WHO EXPERIENCED THE STENT COULD NOT BE DILATED ON ONE SIDE DUE TO SCLEROTIC AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    554304 DISPENSER, CEMENT KIH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention