BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXETER 2.5 I M PLUG 16MM

    MDR report key: 3803279 · Received May 9, 2014

    Report

    Report Number
    0002249697-2014-01749
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K980843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER

    Description of Event or Problem · 1

    THE SALES REP REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A EXETER HIP IMPLANTATION A CEMENT RESTRICTOR WAS BEING USED AS DESCRIBED IN THE SURGICAL TECHNIQUE. THE SALES REP REPORTED THAT WHILST WITHDRAWING THE PLUG INTRODUCER A PART OF THE CEMENT RESTRICTOR CAME OUT DUE TO BREAKAGE OF THE RESTRICTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280649 EXETER 2.5 I M PLUG 16MM IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other