BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFN Ø10 CANN R 130° L340 TAN GREEN

    MDR report key: 2913922 · Received January 14, 2013

    Report

    Report Number
    1719045-2013-00106
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    November 20, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HSB
    PMA / PMN Number
    K973240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS 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: PATIENT WAS IMPLANTED WITH PFN NAIL AND BLADE CONSTRUCT ON UNKNOWN DATE. THE NAIL BROKE POSTOPERATIVELY. THIS WAS REPORTED TO SYNTHES (B)(4) DIRECTLY BY THE PATIENT. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21000 PFN Ø10 CANN R 130° L340 TAN GREEN NAIL HSB SYNTHES MONUMENT 2809472

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLADE