BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZERO-P CONVEX H5 PEEK

    MDR report key: 3171634 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-02816
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    January 20, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    PMA / PMN Number
    K072981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE PRESENT ZERO-P IMPLANT WAS ANALYSED FOR CONFORMANCE TO SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. A FUNCTION TEST WAS PERFORMED AND THE IMPLANT COULD BE ASSEMBLED AS REQUIRED. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. ROOT CAUSE IS UNKNOWN. THERE IS EVIDENCE THAT APPLIED BENDING AND TORSIONAL FORCES DURING THE INSERTION CAUSED THIS SEPARATING OF THIS IMPLANT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE PLATE SEPARATED FROM THE SPACER ON IMPACT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272512 ZERO-P CONVEX H5 PEEK OVE SYNTHES GMBH 3721678

    Patients

    Seq Age Sex Outcome Treatment
    1