BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TTRINITY

    MDR report key: 4645760 · Received April 29, 2014

    Report

    Report Number
    9614209-2014-00034
    Event Type
    Injury
    Date Received
    April 29, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 28, 2014
    Manufacturer
    CORIN LTD.
    Product Code
    LZO
    PMA / PMN Number
    K093472
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE DETAILS, PT NOTES, PATHOLOGY REPORTS, POST PRIMARY AND PRE-REVISION X-RAYS, EXPLANT AND REASON FOR REVISION HAVE BEEN REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION. DEVICE MANUFACTURING RECORDS TO BE REVIEWED. PLEASE NOTE THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA. HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.

    Description of Event or Problem · 1

    TRINITY REVISION AFTER 14 DAYS DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258061 TTRINITY CONSTRAINED THR LZO CORIN LTD. 321.04.354

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TRINITY 6.5MM CANCELLOUS SCREW 321.020| BIOLOX DELTA CERAMIC HEAD 104.3605| TRINITY CERAMIC INSERT 321.04.436| TRINITY 6.4MM CANCELLOUS SCREW 321.015| METAFIX STEM 5/9.0003