BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPENSER, CEMENT

    MDR report key: 3931540 · Received July 14, 2014

    Report

    Report Number
    2520274-2014-12410
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    January 3, 2013
    Report Date
    July 2, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    KIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE VBS GROUP, ONE MINOR COMPLICATION OCCURRED IN ONE UNIDENTIFIED PATIENT. THE UNIDENTIFIED PATIENT HAD A SURGICAL SITE INFECTION, WHICH WAS TREATED BY DEBRIDEMENT AND ANTIBIOTIC THERAPY. THIS REPORT IS FOR AN UNKNOWN VBS SYSTEM WITH AN UNKNOWN LOT NUMBER. 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. 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.

    Description of Event or Problem · 1

    THIS COMPLAINT HAS BEEN RECEIVED FROM A LITERATURE ARTICLE TITLED; SURGICAL PROCEDURE AND INITIAL RADIOGRAPHIC RESULTS OF A NEW AUGMENTATION TECHNIQUE FOR VERTEBRAL COMPRESSION FRACTURES; EUR SPINE J (2013) 22: 1608-1616 BY THALER, MARTIN; LECHNER, RICARDA; NOGLER, MICHAEL; ET AL. THIS LITERATURE ARTICLE PRESENTED A STUDY WHICH INVESTIGATED THE CEMENT LEAKAGE RATE USING QUANTITATIVE MEASURES (COMPUTED TOMOGRAPHY (CT) VOLUMETRY) AND VERTEBRAL BODY HEIGHT RESTORATION AND SPINAL ALIGNMENT AFTER VERTEBRAL BODY STENTING (VBS). CEMENT LEAKAGE WAS COMPARED WITH CONVENTIONAL VERTEBROPLASTY. BETWEEN JANUARY AND NOVEMBER 2009, 56 PATIENTS WERE INCLUDED. ALL PATIENTS HAD SUFFERED OSTEOPOROTIC FRACTURES WITHOUT NEUROLOGICAL DEFICIT. ALL VERTEBRAL FRACTURES WERE LOCATED IN THE LUMBAR SPINE OR THORACOLUMBAR JUNCTION AND WERE CLASSIFIED AS A1 FRACTURES. 29 PATIENTS WERE TREATED USING A CONVENTIONAL VISCOSITY CONTROLLED VERTEBROPLASTY (VERTECEM SYSTEM, SYNTHES (B)(4)). 27 PATIENTS WERE TREATED WITH THE VBS (SYNTHES, (B)(4)) TECHNIQUE AND CEMENT AUGMENTATION WAS PERFORMED WITH PMMA CEMENT (VERTECEM, SYNTHES, (B)(4)). CEMENT VISCOSITY WAS TESTED USING A VISCOMETER (VISCOSAFE, SYNTHES, (B)(4)). PRE AND POST-OPERATIVE X-RAYS, AS WELL AS A POST-OPERATIVE CT SCAN WERE PERFORMED. THE STANDARDIZED PRE- AND POST-OPERATIVE LATERAL AND ANTEROPOSTERIOR RADIOGRAPHS WERE CENTERED ON THE FRACTURED (INDEX) VERTEBRA. ALL RADIOGRAPHS WERE ANALYZED FOR THE IMPROVEMENT IN SAGITTAL ALIGNMENT USING THE COBB TECHNIQUE. FOR CT SCANS, COVERAGE INCLUDED THE TREATED VERTEBRAL LEVELS. CEMENT LEAKAGE WAS EVALUATED AND QUANTIFIED BY A RADIOLOGIST. LOCALIZATION OF CEMENT LEAKAGE WAS CLASSIFIED AS TYPE B (INTO THE BASIVERTEBRAL VEIN), TYPE S (INTO THE SEGMENTAL VEIN) OR TYPE C (CORTICAL LEAKAGE; TYPE C1 INTO THE DISC SPACE; TYPE C2 INTO THE PERIPHERY). A TOTAL OF 27 PATIENTS WERE INCLUDED IN THE VBS GROUP (23 WERE WOMEN AND 4 MEN). A CT EXAMINATION REVEALED CEMENT LEAKAGE IN 12 VERTEBRAE (UNKNOWN NUMBER OF PATIENTS). THE POSTOPERATIVE CT SCAN REVEALED LEAKAGE TYPE B IN ONE LEVEL, TYPE S IN ONE LEVEL, AND TYPE C IN 10 LEVELS. A COMBINED C1 AND C2 LEAKAGE WAS FOUND IN TWO LEVELS. A TOTAL OF 29 PATIENTS WERE INCLUDED IN THE VERTEBROPLASTY GROUP (26 WOMEN AND 3 MEN). THE POSTOPERATIVE CT SCAN REVEALED LEAKAGE TYPE B IN 3 CASES, TYPE S IN 14 CASES AND TYPE C IN 5 CASES (UNKNOWN NUMBER OF PATIENTS). IN BOTH GROUPS, ALL PMMA CEMENT EXTRAVASATIONS WERE ASYMPTOMATIC, THE CEMENT REMAINED IN THE IMMEDIATE AREA OF THE TREATED VERTEBRAE, AND NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO REMOVE EXTRAVASATED CEMENT. IN THE VBS GROUP, ONE MINOR COMPLICATION OCCURRED IN ONE PATIENT. THE PATIENT HAD A SURGICAL SITE INFECTION, WHICH WAS TREATED BY DEBRIDEMENT AND ANTIBIOTIC THERAPY. ALSO IN THE VBS GROUP, TWO PATIENTS HAD A SUBSEQUENT FRACTURE OCCURRING ADJACENT TO TREATED SEGMENTS AND WERE AGAIN TREATED WITH VBS. THE MEAN TIME BETWEEN PRIMARY SURGERY AND ADJACENT FRACTURE WAS 9 DAYS (RANGE 5-13). NO DEVICE-RELATED OR PROCEDURE-RELATED COMPLICATION OCCURRED DURING THE FOLLOW-UP PERIOD. THE MEAN FOLLOW-UP TIME WAS 3.1 MONTHS. IN CONCLUSION THE CLINICAL APPLICATION OF VBS SHOWED A LOWER CEMENT LEAKAGE RATE COMPARED WITH CONVENTIONAL VERTEBROPLASTY. THE RATE OF TYPE B LEAKAGES COULD BE SIGNIFICANTLY REDUCED TO ONE IN THE VBS GROUP. THEREFORE VBS BODY STENTING CAN BE RATED AS A NEW PROMISING OPTION IN THE TREATMENT OF VERTEBRAL COMPRESSION FRACTURES (VCF). THIS COMPLAINT INVOLVES AN UNKNOWN VBS SYSTEM. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409402 DISPENSER, CEMENT KIH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention