BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 2981417 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00646
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. VERTECEM V+ PRODUCT IS NOT SOLD OR DISTRIBUTED IN THE US HOWEVER IT IS SIMILAR TO VERTECEM 510(K) K090435 AND VERTECEM II, 510(K) K121876. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE DOCUMENTS WERE FORWARDED TO THE ACTUAL MANUFACTURER ((B)(4)) FOR STATEMENT. ACCORDING TO THE PRESENT STATEMENT WAS NO CAUSE OF THE FAULT INVESTIGATED. WE QUOTE FROM THIS REPORT: THE MANUFACTURING DOCUMENTATIONS OF THE TWO BATCHES VERTECEM V+ CEMENT KIT (LOT: 1E53040) WERE CHECKED FOR DIFFERENCES. THERE WERE NO DEVIATIONS FOUND IN PRODUCTION, QUALITY CONTROL, STORAGE AND DELIVERY IN THE CONTEXT OF THIS REVIEW.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IRREGULAR CEMENT LEAKAGE. IT WAS REPORTED THE PATIENT PRESENTED WITH IRREGULAR CEMENT LEAKAGE THROUGH THE VASCULAR SEGMENT IN THE SUPERIOR VENA CAVA, THE RIGHT ATRIUM OF HEART, RIGHT VENTRICLE AND INTO THE LUNGS VESSEL WITH DESTRUCTION OF TRICUSPID VALVE WITH SUBSEQUENT CARDIAC INSUFFICIENCY. THIS CONDITION IS IMPERATIVE FOR SURGICAL REMOVAL OF CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85169 VERTECEM V+ CEMENT KIT NDN SYNTHES GMBH 1E53040

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention