BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING

    MDR report key: 12021788 · Received June 17, 2021

    Report

    Report Number
    3005687633-2021-00142
    Event Type
    Injury
    Date Received
    June 17, 2021
    Date of Event
    March 29, 2021
    Report Date
    July 23, 2021
    Manufacturer
    CORCYM S.R.L.
    Product Code
    KRH
    UDI-DI
    08022057015105
    PMA / PMN Number
    K071327
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPLETE MANUFACTURING AND MATERIAL RECORDS REVIEW FOR THE DEVICE HAS BEEN PERFORMED. THE RESULTS CONFIRMED THAT THE DEVICE SATISFIED ALL MATERIAL, VISUAL AND PERFORMANCE STANDARDS REQUIRED AT THE TIME OF MANUFACTURE AND RELEASE. SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF EXPLANT, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. THE MANUFACTURER HAS REQUESTED ADDITIONAL INFORMATION ON THE EVENT AND DEVICE IN QUESTION, BUT NO ADDITIONAL INFORMATION HAS BEEN PROVIDED TO DATE. BASED ON THE AVAILABLE INFORMATION, IT IS NOT POSSIBLE TO DRAW A DEFINITIVE CONCLUSION TO THE REPORTED EVENT. HOWEVER, FROM THE DOCUMENT REVIEW PERFORMED, NO MANUFACTURING DEFICIENCIES HAVE BEEN IDENTIFIED. SHOULD FURTHER INFORMATION BE PROVIDED IN THE FUTURE, THE MANUFACTURER WILL SUBMIT A FOLLOW UP REPORT TO THIS REPORTING ACTIVITY. AT THIS TIME, THE ROOT CAUSE CANNOT BE ESTABLISHED.

    Additional Manufacturer Narrative · 1

    UNKNOWN DEVICE DISPOSITION.

    Description of Event or Problem · 1

    THE MANUFACTURER WAS INFORMED OF THIS EVENT THROUGH THE DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION REPORTED IN THE PATIENT IMPLANT FORM, A MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING MRCS34 WAS IMPLANTED ON (B)(6) 2020. THE DEVICE WAS EXPLANTED ON (B)(6) 2021 AND REPLACED WITH A NEW MRCS34. NO FURTHER INFORMATION IS PRESENTLY AVAILABLE. NO ALLEGATION OF A DEVICE MALFUNCTION NOR OF A SERIOUS INJURY WAS RECEIVED FROM THE SITE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911348 MEMO 3D RECHORD SEMIRIGID ANNULOPLASTY RING MEMO 3D RECHORD KRH CORCYM S.R.L. MRCS34 08022057015105

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention