BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFIT TS

    MDR report key: 6646045 · Received June 16, 2017

    Report

    Report Number
    9614209-2017-00037
    Event Type
    Injury
    Date Received
    June 16, 2017
    Date of Event
    April 20, 2017
    Report Date
    December 1, 2017
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K121563
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, A PATIENT OUTCOME AND THE EXPLANTED DEVICE WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NOT ALL WERE NOT PROVIDED TO CORIN AND THUS THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS HAVE BEEN IDENTIFIED AND REVIEWED. THIS DEVICE CONFORMED TO MATERIAL AND DIMENSIONAL SPECIFICATION. THE EXPLANTED DEVICE WAS RETURNED TO CORIN FOR EXAMINATION. THE RETURNED DEVICE SHOWED SIGNS OF GOOD BONE INGROWTH AND DID NOT SHOW ANY ABNORMAL CHARACTERISTICS. BASED ON THIS, IT CANNOT BE DETERMINED WHETHER THE REPORTED DEVICE CAUSE OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE AND THUS CORIN NOW CONSIDER THIS CASE CLOSED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL REPORT. ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, OPERATIVE NOTES, A PATIENT OUTCOME AND THE EXPLANTED DEVICE HAS BEEN REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS HAVE BEEN PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS WILL BE IDENTIFIED AND REVIEWED. PLEASE NOTE: THIS REPORT IS FILED WITH THE FDA DUE TO AN ADVERSE 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

    TRIFIT TS REVISION AFTER APPROXIMATELY 2 MONTHS DUE TO SUBSIDENCE OF THE STEM.

    Description of Event or Problem · 1

    TRIFIT TS REVISION AFTER APPROXIMATELY 2 MONTHS DUE TO SUBSIDENCE OF THE STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427559 TRIFIT TS TRIFIT TS HIP STEM LZO CORIN MEDICAL 694.1009 311125

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R