BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPENSER, CEMENT

    MDR report key: 3943489 · Received July 18, 2014

    Report

    Report Number
    2520274-2014-12435
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: 2011. THIS REPORT FOR 10 UNKNOWN VERTEBRAL BODY STENTING SYSTEMS, UNKNOWN PART#/LOT#. (B)(6). LECHNER ET AL (2011). RADIOGRAPHIC EVALUATION OF A NEW AUGMENTATION TECHNIQUE (VERTEBRAL BODY STENTING) FOR VERTEBRAL COMPRESSION FRACTURES. EUR SPINE JOURNAL. VOL: 20, PAGE# 2047. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ARTICLE; LECHNER ET AL (2011). RADIOGRAPHIC EVALUATION OF A NEW AUGMENTATION TECHNIQUE (VERTEBRAL BODY STENTING) FOR VERTEBRAL COMPRESSION FRACTURES. EUR SPINE JOURNAL. VOL: 20, PAGE# 2047. 27 CONSECUTIVE PATIENTS WITH VERTEBRAL COMPRESSION FRACTURES IN THE THORACO-LUMBAR JUNCTION (T10- L5) WITHOUT NEUROLOGICAL DEFICIT WERE INCLUDED IN THE PRESENT STUDY. 17 PATIENTS HAD SINGLE LEVEL VERTEBRAL FRACTURE, WHILE 10 PATIENTS SUFFERED FROM MULTIPLE VERTEBRAL FRACTURES (2-5 VERTEBRAE). A TOTAL OF 55 VERTEBRAL COMPRESSION FRACTURES WITH A MEAN OF 1.9 PER PATIENT WERE INVESTIGATED. PREOPERATIVELY AND POSTOPERATIVELY LATERAL AND ANTERIOR-POSTERIOR X-RAYS, AS WELL AS A POSTOPERATIVELY COMPUTED TOMOGRAPHY (CT) SCANS WERE PERFORMED. WE ASSESSED COBB ANGLE CHANGES (SEGMENTAL AND VERTEBRAL KYPHOSIS), VERTEBRAL BODY HEIGHTS CHANGES AND CEMENT LEAKAGE FOLLOWING VERTEBRAL BODY STENTING (VBS). CEMENT LEAKAGE WAS EVALUATED AND QUANTIFIED BY AN EXPERIENCED RADIOLOGIST WITH VOLUMETRY. THE VOLUME OF CEMENT INSIDE AND OUTSIDE THE VERTEBRAL BODIES AS WELL AS THE LOCALISATION OF THE CEMENT LEAKAGE, ACCORDING TO YEOM WAS DETERMINED. (TYPE B: INTO THE BASIVERTEBRAL VEIN / TYPE S: INTO THE SEGMENTAL VEIN / TYPE C: CORTICAL LEAKAGE: TYPE C1 INTO THE DISC SPACE, TYPE C2 INTO THE PERIPHERY). SIGNIFICANT IMPROVEMENT FOR HP (2.2 MM), HM (7.3 MM), AND HA (3.6 MM) WAS SEEN. THE MEAN IMPROVEMENT OF SEGMENTAL KYPHOSIS WAS 5.8° (RANGE: -13.2° TO 38.2°, P < 0.05). THE MEAN IMPROVEMENT OF VERTEBRAL KYPHOSIS WAS 3.5° (RANGE: 14.4 TO 25°, P < 0.05). THE MEAN INJECTED VOLUME OF CEMENT PER VERTEBRAL BODY WAS 7.334 CM3 (3.34 TO 10.19). THE CT EXAMINATION REVEALED CEMENT LEAKAGE IN 12 VERTEBRAE. THE POSTOPERATIVE CT SCAN REVEALED LEAKAGE TYPE B IN 1 LEVEL (0.059 CM3), TYPE S IN 1 LEVEL (0.071 CM3) AND TYPE C IN 10 LEVELS (C1: MEAN: 0.548 CM3, RANGE: 0.072 TO 1.638 / C2: MEAN: 0.092 CM3, RANGE: 0.014 TO 0.313). A COMBINED C1 AND C2 LEAKAGE WAS FOUND IN TWO LEVELS. THE AVERAGE AMOUNT OF CEMENT OUTSIDE THE VERTEBRAE WAS 0.2817 CM3 (RANGE: 0.014 TO 1.638), WHICH WAS 1.362% OF THE APPLIED TOTAL VOLUME OF CEMENT. ALL PATIENTS WITH CEMENT EXTRAVASATIONS WERE ASYMPTOMATIC. THIS IS REPORT 1 OF 1 FOR (B)(4). THIS REPORT FOR 10 UNKNOWN VERTEBRAL BODY STENTING SYSTEMS, UNKNOWN PART#/LOT#.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422678 DISPENSER, CEMENT KIH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1