BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR VISTAFIX VXI300 IMPLANT 4MM

    MDR report key: 11625858 · Received April 7, 2021

    Report

    Report Number
    6000034-2021-01042
    Event Type
    Injury
    Date Received
    April 7, 2021
    Report Date
    July 6, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    FZE
    UDI-DI
    09321502021722
    PMA / PMN Number
    K945154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS HAVE BEEN MADE TO B5 (DESCRIPTION OF EVENT - DATE OF THIS REPORT), D4 (CATALOG NO AND LOT NO UPDATED), D9 (DEVICE AVAILABLE FOR EVALUATION), G1 (MANUFACTURING SITE), H3 (DEVICE EVALUATED BY MANUFACTURER), H6 (CLINICAL CODE & IMPACT CODE). THIS REPORT IS SUBMITTED ON (B)(6) 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN IMPLANT LOSS. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON 07 APRIL 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSSEOINTEGRATION RESULTING IN IMPLANT LOSS. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526987 COCHLEAR VISTAFIX VXI300 IMPLANT 4MM COCHLEAR BAHA VISTAFIX SYSTEM FZE COCHLEAR BONE ANCHORED SOLUTIONS AB 93101 09321502021722

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention