BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 2986131 · Received March 1, 2013

    Report

    Report Number
    8030965-2013-00683
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 31, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WE HAVE NOT RECEIVED THE DEVICE FOR INVESTIGATION. THE MANUFACTURING DOCUMENTS WERE REVIEWED REGARDING DEVIATIONS DURING THE MANUFACTURING PROCESS. WE COULD NOT DETECT ANY DEVIATIONS DURING PRODUCTION, QUALITY CONTROL, STORAGE AND DELIVERY PROCEDURES. NO PRODUCT RELATED FAULT WAS FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. A MANUFACTURING AND/OR PRODUCT INVESTIGATION COULD NOT BE PERFORMED AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: CEMENT GUN BROKE. THE REPORTING SURGEON FELT THE HANDLE OF THE DEFEAT VERTECEM V+ CEMENT GUN WAS TIGHT DURING MIXING AND FILLING. AS A RESULT, THE CEMENT GUN BROKE. THE SURGEON USED A SPARE GUN WHICH WAS COMPARATIVELY SMOOTHER AND EASIER TO FILL THE INJECTION SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89232 VERTECEM V+ CEMENT KIT NDN SYNTHES GMBH 1C53030

    Patients

    Seq Age Sex Outcome Treatment
    1