BEUDAMED
    FDA Adverse Event Injury Summary report: N

    METAFIX

    MDR report key: 5913826 · Received August 30, 2016

    Report

    Report Number
    9614209-2016-00145
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 16, 2016
    Report Date
    October 26, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    LZO
    PMA / PMN Number
    K082525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) FINAL REPORT. ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, DEVICE DETAILS, REASON FOR REVISION AND THE EXPLANTED DEVICES WERE REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, NONE THESE WERE NOT PROVIDED AND THEREFORE THERE WAS ONLY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE NOT PROVIDED AND THUS THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE EXPLANTED DEVICES WERE NOT RETURNED TO CORIN FOR EXAMINATION. BASED ON THE INFORMATION PROVIDED, IT CANNOT BE DETERMINED AT THIS TIME WHETHER OR NOT THE CORIN DEVICES CAUSED OR CONTRIBUTED TO THE PATIENT'S EXPERIENCE. CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY ADDITIONAL INFORMATION BE PROVIDED, THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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). ADDITIONAL INFORMATION, INCLUDING POST PRIMARY AND PRE REVISION X-RAYS, DEVICE DETAILS, REASON FOR REVISION AND THE EXPLANTED DEVICES HAVE 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 RELEVANT DEVICE MANUFACTURING RECORDS WILL BE RETRIEVED AND REVIEWED UPON RECEIPT OF THE APPROPRIATE DEVICE DETAILS. 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

    TRINITY / METAFIX REVISION, REASON FOR REVISION AND THE LENGTH OF TIME THAT THE DEVICES WERE IMPLANTED IS UNKNOWN.

    Description of Event or Problem · 1

    TRINITY / METAFIX REVISION, LENGTH OF TIME THE DEVICES WERE IMPLANTED IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565230 METAFIX CORIN METAFIX HIP STEM LZO CORIN MEDICAL NOT PROVIDED NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization