BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTSCR Ø2 SELF-TAP L38 TAN

    MDR report key: 3260188 · Received August 1, 2013

    Report

    Report Number
    8030965-2013-04563
    Event Type
    Malfunction
    Date Received
    August 1, 2013
    Report Date
    July 9, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    PMA / PMN Number
    K112583
    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. (B)(4) WAS INITIATED AND IT WAS DETERMINED THAT NO FURTHER ACTIONS ARE NECESSARY, ALL OF THE INVOLVED LOT NUMBERS WERE PART OF THIS PREVIOUS INVESTIGATION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SHOWED THAT THE LABELING TEXT ON THE PACKAGING SHOWS A WRONG LENGTH (L36MM INSTEAD OF L38MM). THE LABEL TEXT DOES NOT MATCH THE SPECIFICATIONS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE HEADLINE OF THE LABEL FOR THE FIVE SCREWS SAYS L36 INSTEAD OF L38. THE MULTILINGUAL TEXT IS CORRECT WITH L38. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359869 CORTSCR Ø2 SELF-TAP L38 TAN HWC SYNTHES GMBH 3795401

    Patients

    Seq Age Sex Outcome Treatment
    1