BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAITHLON P/A CR BEADED #4L

    MDR report key: 1629259 · Received February 5, 2010

    Report

    Report Number
    9610726-2009-00283
    Event Type
    Malfunction
    Date Received
    February 5, 2010
    Date of Event
    August 8, 2006
    Report Date
    February 5, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    MBH
    PMA / PMN Number
    K051380
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF A QUALITY SYSTEM IMPROVEMENT PLAN STRYKER CORPORATION CONDUCTED A 2 YEAR RETROSPECTIVE MDR REVIEW TO ENSURE APPROPRIATE MDR REPORTING DECISIONS. EVENTS REPORTED TO STRYKER FROM (B) (6) 2006 TO (B) (6) 2008 WERE THE SCOPE OF THIS RETROSPECTIVE REVIEW. THESE EVENTS ARE PART OF A RETROSPECTIVE SUMMARY REPORT BEING SUBMITTED UNDER EXEMPTION # (B) (4). THERE IS 1 EVENT ASSOCIATED WITH THIS EVENT TYPE (POTENTIAL MANUFACTURING ERROR) AND PRODUCT CODE (MBH).

    Description of Event or Problem · 1

    POTENTIAL MANUFACTURING ERROR. THE USUAL WHITE COATING ASSOCIATED WITH PA WAS MISSING AND THE IMPLANT APPEARS TO BE A BEADED ONLY ALTHOUGH THE BOX STATED PA. THE IMPLANT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAITHLON P/A CR BEADED #4L IMPLANT MBH STRYKER ORTHOPAEDICS LIMERICK NA SA7JF

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other