BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAFIX

    MDR report key: 5852816 · Received August 8, 2016

    Report

    Report Number
    9614209-2016-00025
    Event Type
    Malfunction
    Date Received
    August 8, 2016
    Date of Event
    September 22, 2014
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JDI
    PMA / PMN Number
    K082525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1195 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP IN ERROR. THIS CASE WAS SUBMITTED AS THE RESULT OF A RETROSPECTIVE REVIEW. IT WAS REPORTED THAT A METAFIX STEM INTRODUCER DOESN'T WORK, THE REPORTED DEVICE WAS NOT USED IN SURGERY. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS AND THE RETURN OF THE INSTRUMENT WAS REQUESTED IN ORDER TO PROGRESS WITH THIS INVESTIGATION, HOWEVER, THESE WERE NOT PROVIDED, THEREFORE, THERE WAS ONLY VERY LIMITED INFORMATION AVAILABLE FOR THE INVESTIGATION. THE APPROPRIATE DEVICE DETAILS WERE NOT PROVIDED AND THE RELEVANT DEVICE MANUFACTURING RECORDS COULD NOT BE IDENTIFIED OR REVIEWED. THE REPORTED INSTRUMENT WAS NOT RETURNED TO CORIN (B)(4) AND THE INITIAL REPORTER TO CORIN (B)(4) DID NOT CONFIRM IN WHAT WAY THE INSTRUMENT WAS BROKEN. BASED ON THIS CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION COME TO LIGHT THIS CASE CAN BE RE-OPENED FOR FURTHER INVESTIGATION. 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

    IT WAS REPORTED THAT A METAFIX STEM INTRODUCER DOESN'T WORK. THE REPORTED DEVICE WAS NOT USED IN SURGERY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507693 METAFIX METAFIX HIP STEM JDI CORIN MEDICAL 340.360 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other