BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL, STANDARD 10X390MM

    MDR report key: 1071828 · Received July 8, 2008

    Report

    Report Number
    9610622-2008-00104
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    May 24, 2008
    Report Date
    June 23, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    JDS
    PMA / PMN Number
    K003018
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DEVELOPMENT DEPARTMENT CLASSIFIED THE RISK FOR INJECTION AS MINIMAL AS THE GUARANTEED PERIOD OF 59 MONTHS HAS A SAFETY PERIOD. FURTHER WE CAN REFERENCE TEST RESULTS CARRIED OUT BY ANOTHER COUNTRY'S MFR, WHERE IT WAS PROVED IN SEVERAL LONGITUDINAL STUDIES THAT THE IMPLANTS WERE STILL STERILE AFTER 59 MONTHS AND AFTER 71 MONTHS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA THE SALES REPRESENTATIVE THAT IN 2008, A T2 TIBIAL NAIL WAS IMPLANTED. IT IS FURTHER REPORTED THAT THE EXPIRATION DATE OF THIS DEVICE 2008/03.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL NAIL, STANDARD 10X390MM IMPLANT JDS STRYKER OSTEOSYNTHESIS KIEL NA K861318

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other