BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDPOR TITAN OFW - MTB - RIGHT

    MDR report key: 3649567 · Received February 27, 2014

    Report

    Report Number
    0008010177-2014-00053
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 27, 2014
    Report Date
    January 30, 2014
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FTM
    PMA / PMN Number
    K040364
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED DEVICE WAS RETURNED AND THEREFORE, THE EVENT COULD BE CONFIRMED. THIS EVENT CAN BE CLASSIFIED AS MANUFACTURING RELATED. THE DEVICE IS MANUFACTURED BY STRYKER ORTHOBIOLOGICS AND RELEVANT PEOPLE WERE CONTACT TO ADDRESS THE EVENT. NO FURTHER INSPECTIONS (FUNCTIONAL, DIMENSIONAL) WERE PERFORMED, BECAUSE THE EVENT IS PACKAGE RELATED. NON CONFORMANCE (NC) # (B)(4) WAS INITIATED TO PREVENT REOCCURRENCE. THE ACTIONS OF THE NON-CONFORMANCE ARE ONGOING.

    Description of Event or Problem · 1

    DURING OPENING OF THE MEDPOR OUTER PACKAGE, THE OR NURSE SAW SOMETHING IN THE INNER PACKAGE WHICH LOOKED LIKE A HAIR. THEY DIDN'T OPEN THE INNER PACKAGE.

    Description of Event or Problem · 1

    DURING OPENING OF THE MEDPOR OUTER PACKAGE, THE O.R. NURSE SAW SOMETHING IN THE INNER PACKAGE WHICH LOOKED LIKE A HAIR. THEY DIDN'T OPEN THE INNER PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120197 MEDPOR TITAN OFW - MTB - RIGHT IMPLANT FTM STRYKER ORTHOBIOLOGICS-MALVERN A1308035

    Patients

    Seq Age Sex Outcome Treatment
    1