BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 3024993 · Received March 28, 2013

    Report

    Report Number
    8030965-2013-01146
    Event Type
    Malfunction
    Date Received
    March 28, 2013
    Report Date
    February 27, 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

    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: MIXER IS BROKEN. THE MIXER PISTON BROKE DURING THE FILLING OF SYRINGES. THERE WAS NO CONSEQUENCE TO THE PATIENT AND THE SURGERY WAS DELAYED 20 PERCENT. THE INCIDENT DID NOT REQUIRE FURTHER TREATMENT AS THERE WAS ANOTHER DEVICE TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127581 VERTECEM V+ CEMENT KIT NDN SYNTHES GMBH 2B53053

    Patients

    Seq Age Sex Outcome Treatment
    1