BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD, FIXATION, INTRAMEDULLARY

    MDR report key: 4156507 · Received October 9, 2014

    Report

    Report Number
    2520274-2014-14026
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    September 13, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: HWC. THIS REPORT IS FOR ONE UNKNOWN EXPERT ANTEGRADE FEMORAL NAIL (A2FN)/UNKNOWN LOT NUMBER. IMPLANT AND EXPLANT DATE UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4).DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGEON REMOVED THE EXPERT ANTEGRADE FEMORAL NAIL (A2FN) AND HELICAL BLADE AND EXCHANGED WITH OTHER IMPLANT DUE TO HELICAL BLADE CUTOUT. THERE WAS NO BREAKAGE OR BENDING OF THE IMPLANT AND NO PATIENT INFECTION. THIS REPORT IS 1 OF 2 FOR COM-(B)(4).

    Description of Event or Problem · 1

    REPORTEDLY THE EVENT WAS NOT AN IMPLANT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635306 ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention