BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVIOS TRIAL-IMPL CURVED SIZ 6 GOLD

    MDR report key: 2932677 · Received January 29, 2013

    Report

    Report Number
    8030965-2013-00246
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES TESTS PERFORMED DID NOT REVEAL ANY PROBLEMS WITH THE CHRONOS IMPLANT AS WELL AS ALL THE TRIAL IMPLANTS. ALL ARTICLES HAVE BEEN MEASURED, CHECKED AND FOUND TO BE ACCORDING TO THE GIVEN SPECIFICATION. IT IS NOTED THAT THE TRIAL IMPLANTS HAVE A FLAT SURFACE NOT LIKE THE CHRONO IMPLANT ITSELF WHERE WE HAVE TEETH. THEREFORE IT COULD GET THE IMPRESSION, AFTER THE TEETH SUBSIDED, THAT THE IMPLANT IS LOOSE AND DOES NOT FIT ACCORDINGLY. THE RETURNED ARTICLES WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. NO PRODUCT FAULT COULD BE DETECTED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CERVIOS CHRONOS CURVED IMPLANT SIZE 7MM SEEMS TO BE SMALLER THAN TRIAL CERVIOS TRIAL IMPLANT CURVED SIZE 7 AND CORRESPONDS TO CERVIOS TRIAL IMPLANT CURVED SIZE 6. THE IMPLANT IS LABELS 7MM ON THE BOX AS WELL AS THE IMPLANT. THE TRIAL IMPLANTS WERE RECEIVED INTACT. THIS IS 5 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38604 CERVIOS TRIAL-IMPL CURVED SIZ 6 GOLD CERVIOS TRIAL IMPLANT HWT SYNTHES GMBH 3404672

    Patients

    Seq Age Sex Outcome Treatment
    1 CERVIOS CHRONOS, CERVIOS TRIAL IMPLANTS