BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX ANKLE ARTHRODESIS NAIL SYSTEM

    MDR report key: 1633655 · Received March 17, 2010

    Report

    Report Number
    2242816-2010-00033
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 26, 2010
    Report Date
    March 2, 2010
    Manufacturer
    EBI, LLC
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PARTS INVOLVED IN EVENT:PART NO. LOT NO. DESCRIPTION EXP. DATE MFG. DATE14-405044 006710 TI-DOUBLE LEAD CORTICAL SCREW 04/30/2017 04/20/2007;14-405056 287890 TI-DOUBLE LEAD CORTICAL SCREW 10/31/2017 11/09/2007.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT SCREW WOULD NOT GAIN PURCHASE WITH THE BONE.PATIENT OUTCOME: NO ADVERSE AFFECT REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHOENIX ANKLE ARTHRODESIS NAIL SYSTEM TI-DOUBLE LEAD CORTICAL SCREW HWC EBI, LLC 329700

    Patients

    Seq Age Sex Outcome Treatment
    1