BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPAN

    MDR report key: 19425969 · Received May 30, 2024

    Report

    Report Number
    3005977257-2024-00002
    Event Type
    Malfunction
    Date Received
    May 30, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 10, 2024
    Manufacturer
    LESSPINE INNOVATIONS LLC
    Product Code
    PEK
    PMA / PMN Number
    K213266
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE CHALLENGING ANATOMY PROHIBITED THE DEVICE FROM BEING ADEQUATELY COMPRESSED AND LOCKED. NO PATIENT HARM WAS NOTED. MEDICAL INTERVENTION WAS REQUIRED TO AVOID SERIOUS INJURY.

    Description of Event or Problem · 0

    ANATOMY WAS CHALLENGING TO COMPRESS AND LOCK TO THE 18MM INSPAN IMPLANT (THICK SPINOUS PROCESS AND HARD BONE). IT WAS NOTICED POST-SURGERY THAT THE IMPLANT WAS NOT COMPRESSED ENOUGH FOR PROPER IMPLANT LOCKING. A REVISION IS SCHEDULED TO REPLACE THE UNLOCKED IMPLANT. NO PATIENT HARM IS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423460 INSPAN INSPAN PEK LESSPINE INNOVATIONS LLC GL02

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Hospitalization| R