BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIBIAL NAIL, STANDARD 10X420MM

    MDR report key: 1071832 · Received July 8, 2008

    Report

    Report Number
    9610622-2008-00107
    Event Type
    Malfunction
    Date Received
    July 8, 2008
    Date of Event
    March 22, 2008
    Report Date
    June 13, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    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

    DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFO BECOMES AVAILABLE, IT WILL SUBMITTED ON A SUPPLEMENTAL REPORT. THE DEVELOPMENT DEPARTMENT CLASSIFIED THE RISK FOR INFECTION AS MINIMAL AS THE GUARANTEED PERIOD OF 59 MONTHS HAS A SAFETY PERIOD. FURTHER WE CAN REFERENCE ON TEST RESULTS CARRIED OUT BY FOREIGN CO 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 THEY BELIEVE EXPIRED TRAUMA PRODUCT WAS IMPLANTED. IT IS FURTHER REPORTED THAT THE CUSTOMER HAS REQUESTED INFORMATION ON THE POSSIBLE RISKS TO THE PATIENT. IT IS REPORTED THIS DEVICE HAS AN EXPIRATION DATE OF 2008/02.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL NAIL, STANDARD 10X420MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K934587

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other