BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBI TROCHANTERIC NAIL SYSTEM

    MDR report key: 1014032 · Received March 14, 2008

    Report

    Report Number
    2242816-2008-00034
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Date of Event
    February 29, 2008
    Report Date
    March 6, 2008
    Manufacturer
    EBI
    Product Code
    JDS
    PMA / PMN Number
    K050118
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L CATALOG# 279890, LOT # 101149. DEVICE MANUFACTURE DATE: 6/2005.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LAG SCREW INSERTERS STRIPPED DURING USE. PATIENT STATUS IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EBI TROCHANTERIC NAIL SYSTEM JDS EBI 58008

    Patients

    Seq Age Sex Outcome Treatment
    1