BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M3 STAND-ALONE ANTERIOR LUMBAR SYSTEM

    MDR report key: 8713168 · Received June 19, 2019

    Report

    Report Number
    3006494201-2019-00006
    Event Type
    Injury
    Date Received
    June 19, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 19, 2019
    Manufacturer
    CORELINK SURGICAL LLC
    Product Code
    OVD
    PMA / PMN Number
    K180814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    ON 5/22/2019, CORELINK WAS MADE AWARE OF THE FOLLOWING INCIDENT. A (B)(6) MALE PATIENT UNDERWENT L5-S1, ALIF FUSION SURGERY. IMMEDIATELY FOLLOWING PROCEDURE, PATIENT WAS FINE AND PER THE DOCTOR, PROCEDURE WAS CONSIDERED A SUCCESS. AT THE 2 WEEK POST-SURGICAL FOLLOW UP VISIT, PATIENT APPEARED TO BE DOING FINE AND HEALING AS EXPECTED. AT APPROXIMATELY 3 WEEKS POST-OP, PATIENT BEGAN TO COMPLAIN ABOUT A SORE AT THE SURGICAL SITE WHICH WAS OOZING FLUID. PATIENT THEN DEVELOPED AN INFECTION AT THE SURGICAL SITE, WHICH WAS DETERMINED TO BE SERRATIA, A GRAM NEGATIVE ORGANISM. THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR TREATMENT OF THE INFECTION FOR APPROXIMATELY 1 WEEK. IN A FOLLOW-UP CALL WITH THE SURGEON ON (B)(6), PATIENT APPEARS TO BE DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    505101 M3 STAND-ALONE ANTERIOR LUMBAR SYSTEM INVERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD CORELINK SURGICAL LLC 3AS2740-1512 SM099560

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization