BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP-SCR Ø4 W/FINE TIP F/SYNFIX-LR L25

    MDR report key: 3240364 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04415
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MAX
    PMA / PMN Number
    K072253
    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

    ADDITIONAL EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE MEASURABLE DIMENSIONS OF THE SUBMITTED SYNFIX ARTICLES WERE REVIEWED. IT WAS FOUND THAT THESE CORRESPOND TO THE DRAWINGS AND THE AO / ASIF SPECIFICATIONS. THE INSPECTION OF THE RAW MATERIAL TEST CERTIFICATE AND THE PRODUCTION DOCUMENTS HAS REVEALED THAT DIFFERENCES IN MATERIAL ANALYSIS, TENSILE STRENGTH, STRUCTURAL STABILITY AND THE PRODUCTION WERE OBSERVED. THE VALUES CORRESPOND TO THE AO / ASIF SPECIFICATIONS AND INTERNATIONAL STANDARDS. THE FAULTY IMPLANTS SHOW VARIOUS DEFORMATIONS WHICH WERE OF THE TRYING OF THE APPLICATION. HOWEVER, A ROOT CAUSE CAN NOT BE DETERMINED AFTERWARDS. THE IMPLANTS FULLY COMPLY WITH OUR SPECIFICATIONS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROCEDURE ON AN UNKNOWN DATE, THE SURGEON FOUND IT VERY DIFFICULT TO INSERT THE SCREWS INTO THE CAGE. IT WAS DIFFICULT TO POSITION THE SCREWS. THE CAGE AND SCREWS WERE NOT IMPLANTED. THIS IS REPORT 6 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339595 LCP-SCR Ø4 W/FINE TIP F/SYNFIX-LR L25 MAX SYNTHES GMBH 8271243

    Patients

    Seq Age Sex Outcome Treatment
    1