BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 14MM

    MDR report key: 2945738 · Received January 4, 2013

    Report

    Report Number
    9610726-2013-90003
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    AS THE PLUG WAS BEING INTRODUCED IT WAS NOTED THAT IT DID NOT DISENGAGE FROM THE INTRODUCER AND HAD CRACKED AND REMAINED LODGED IN THE INTRODUCER. AN ALTERNATIVE PLUG WAS USED AND THE CASE PROCEEDED UNEVENTFULLY WITHOUT ANY DELAY OR PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5834 EXETER 2.5 I M PLUG 14MM IMPLANT JDI STRYKER ORTHOPAEDICS LIMERICK NA N615KL5986

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK