BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/125MM

    MDR report key: 2999364 · Received March 12, 2013

    Report

    Report Number
    8030965-2013-00830
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 14, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K093668
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    510K#: K093668. THE PERFORMED INVESTIGATION HAS SHOWN THAT THE MACHINED END OF THE MIS ROD HAS A NOTCH WHICH DOES NOT MEET THE SPECIFICATIONS. HOWEVER, THIS DOES NOT AFFECT THE FUNCTION OF THE MIS ROD WHICH EASILY CAN BE CONNECTED TO THE ROD HOLDER. THE COMPLAINED MIS ROD WAS SENT FOR FURTHER INVESTIGATION TO THE MANUFACTURING PLANT. THE RESULTS SHOW THAT THIS IMPLANT HAS BEEN PRODUCED IN MAY 2011 AND NO ABNORMALITIES WERE FOUND ON PRODUCTION DOCUMENTS. NO FURTHER COMPLAINT ON THIS ITEM IS KNOWN. BASED ON THESE RESULTS, NO FURTHER MEASURES ARE INITIATED AND THIS CASE IS EVALUATED AS AN ISOLATED CASE. THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODES: MNH, MNI, KWO, KWP. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE DEVICE HISTORY RECORD REVIEW REPORTED THE FOLLOWING: 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: DURING THE REFILL OF A LOAN SET IT WAS NOTICED THAT THERE WAS A DEFORMITY IN THE CONNECTION PART OF THE MIS ROD. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102824 5.5MM TI MIN INVASIVE CURVED ROD 200MM RADIUS/125MM NKB SYNTHES GMBH 3802893

    Patients

    Seq Age Sex Outcome Treatment
    1