BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 2981660 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00653
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS 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. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. METHOD: ADDITIONAL INFORMATION NOT PREVIOUSLY REPORTED. WE HAVE FORWARDED THE COMPLAINED ARTICLE TO THE RESPONSIBLE PRODUCT DEVELOPMENT CENTER FOR EVALUATION. THE INVESTIGATION SHOWS NO OBVIOUS DAMAGE. UNFORTUNATELY THE REASON FOR THIS HAPPENING CANNOT EXACTLY BE DETERMINED SO FAR. NO PRODUCT FAULT COULD BE DETECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN PORTUGAL REPORTED A SURGEON WAS UNABLE TO PUSH AND PULL THE VERTECEM V+ CEMENT KIT HANDLE. ONLY AFTER FORCING THE DEVICE FOR 3/4 MINUTES IT STARTED WORKING. THE SURGEON HAS A LOT OF EXPERIENCE IN USING VERTECEM V+.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84041 VERTECEM V+ CEMENT KIT CEMENT NDN SYNTHES GMBH 1E53040

    Patients

    Seq Age Sex Outcome Treatment
    1