BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIS PROXIMAL ROD EM

    MDR report key: 2940682 · Received December 12, 2012

    Report

    Report Number
    2249697-2012-02619
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    DURING INCOMING INSPECTION AT THE DISTRIBUTION CENTER, AN EVENT REGARDING MISSING THREADING ON MIS PROXIMAL RODS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIS PROXIMAL ROD EM INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA RD7C143

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other