BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P VA LORDOTIC H6 PEEK

    MDR report key: 3133350 · Received May 29, 2013

    Report

    Report Number
    8030965-2013-02388
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K112068
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE DEVICE HISTORY RECORD OF THE ZERO-P VA IN QUESTION WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE FUNCTION TEST HAS SHOWN THAT THE IMPLANT CAN BE ASSEMBLED AND DISASSEMBLED AS REQUIRED. ALSO IT STAYS IN POSITION AFTER ASSEMBLING AND CAN JUST BE REMOVED WITH EFFORT. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. THE EXACT CAUSE OF THIS OCCURRENCE CAN NOT BE DEFINED. IT IS POSSIBLE THAT BENDING AND/OR ROTATIONAL FORCES WERE APPLIED ONTO THE IMPLANT HOLDER DURING THE INSERTION, WHICH CAN LEAD TO A SEPARATION. THE MISSING ARROW WAS INTRODUCED IN MARCH 2011 DURING A DESIGN ADAPTATION. THIS ZERO-P VA WAS MANUFACTURED PREVIOUSLY AND DOES NOT HAVE THIS FEATURE THEREFORE. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: REPORTEDLY THERE IS NO ARROW ON THE ZERO-P VA IMPLANT AND THE PLATE IS DISCONNECTED. THERE WAS NO PART REMAINING IMPLANTED IN THE PATIENT, DELAY OF SURGERY -20% AND NO ADVERSE EFFECT WAS REPORTED. THE EVENT DID NOT REQUIRE FURTHER TREATMENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235096 ZERO-P VA LORDOTIC H6 PEEK OVE SYNTHES GMBH 3621228

    Patients

    Seq Age Sex Outcome Treatment
    1