BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    METAFIX

    MDR report key: 5849673 · Received August 5, 2016

    Report

    Report Number
    9614209-2016-00063
    Event Type
    Malfunction
    Date Received
    August 5, 2016
    Report Date
    August 5, 2016
    Manufacturer
    CORIN MEDICAL
    Product Code
    JDI
    PMA / PMN Number
    K082525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    C-1082 INITIAL REPORT. THIS INITIAL REPORT IS BEING SUBMITTED NOW AS IT WAS ERRONEOUSLY SUBMITTED AS A FOLLOW-UP REPORT IN ERROR. THIS CASE WAS SUBMITTED AS A RESULT OF A RETROSPECTIVE REVIEW. ADDITIONAL INFORMATION, INCLUDING DEVICE DETAILS, PATIENT OUTCOME AND RETURN OF THE DEVICE WERE REQUESTED IN ORDER TO PROGRESS WITH THE INVESTIGATION, HOWEVER, NOT ALL WERE PROVIDED, THEREFORE THERE WAS LIMITED INFORMATION AVAILABLE FOR THIS INVESTIGATION. NEITHER DEVICE DETAILS OR THE DEVICE ITSELF WERE PROVIDED TO CORIN UK, THEREFORE, DEVICE MANUFACTURING RECORDS COULD NOT BE RETRIEVED OR REVIEWED AND A FAILURE MODE OR ROOT CAUSE COULD NOT BE IDENTIFIED. BASED ON THIS, CORIN NOW CONSIDERS THIS CASE CLOSED, HOWEVER, SHOULD ANY NEW INFORMATION BE PROVIDED THIS CASE MAY BE RE-OPENED FOR FURTHER INVESTIGATION. 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

    IT WAS REPORTED THAT A METAFIX STEM PUNCH WAS DAMAGED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504348 METAFIX CORIN METAFIX HIP STEM JDI CORIN MEDICAL 340.362 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown