BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2011664 · Received March 3, 2011

    Report

    Report Number
    8030965-2011-00035
    Event Type
    Injury
    Date Received
    March 3, 2011
    Date of Event
    January 14, 2011
    Report Date
    February 2, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HSB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510 (K) # WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT REC'D FROM SYNTHES (B)(6). PT IN (B)(6) IMPLANTED WITH HARDWARE ON (B)(6) 2010 FOR TROCHANTERIC FRACTURE. ON (B)(6) 2011 PT COMPLAINED OF PAIN AND X-RAYS WERE TAKEN (B)(6) 2011. PT REPORTED THAT THE NAIL WAS SLIGHTLY DEFORMED. X-RAYS TAKEN (B)(6) 2011 FROM SEVERAL POSITIONS GAVE PHYSICIAN A REASON TO BELIEVE THE NAIL MAY BE BROKEN. HARDWARE WAS REMOVED (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NAIL HSB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention