BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VELOFIX TLIF CAGE

    MDR report key: 11363884 · Received February 23, 2021

    Report

    Report Number
    9617297-2021-00004
    Event Type
    Malfunction
    Date Received
    February 23, 2021
    Date of Event
    January 21, 2021
    Report Date
    February 23, 2021
    Manufacturer
    U&I CORPORATION
    Product Code
    MAX
    PMA / PMN Number
    K172419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURED IN (B)(6), TO A (B)(6) PATIENT. HE HAD A SURGERY TO INSERT VELOFIX TLIF CAGES ON (B)(6) 2021. ON (B)(6) 2021, IT WAS FOUND THAT HE EXPERIENCED THE CAGE MIGRATION IN L4-L5 TOWARD THE POSTERIOR. UPON REVIEWING THE X-RAY IMAGE OF THE INITIAL SURGERY, IT APPEARS THAT THE CAGE WAS LOCATED RATHER MORE POSTERIORLY THAN THE APPROPRIATE POSITION. ACCORDING TO THE LITERATURE REVIEW, IT IS KNOWN THAT POSTERIORLY LOCATED CAGES ARE MORE PRONE TO DEVELOPING POSTERIOR CAGE MIGRATION. WE'LL GIVE THE INSTRUCTION TO THE SURGEON ABOUT HOW TO LOCATE THE CAGE PROPERLY. NO PLAN TO HAVE A REVISION SURGERY ACCORDING TO THE SURGEON'S DECISION. THE PATIENT'S CONDITION IS GOING TO BE MONITORED.

    Description of Event or Problem · 1

    THE MALE PATIENT HAD A SURGERY TO INSERT VELOFIX TLIF CAGE ON (B)(6) 2021. ON (B)(6) 2021, IT WAS FOUND THAT HE EXPERIENCED THE CAGE MIGRATION IN L4-L5 TOWARD THE POSTERIOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261145 VELOFIX TLIF CAGE INTERVERTEBRAL BODY FUSION DEVICE MAX U&I CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR