BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KONG-TL VBR E, EXPANDABLE BODY, STANDALONE, XS, Ø 19 MM X 22 - 29 MM

    MDR report key: 21858459 · Received April 17, 2025

    Report

    Report Number
    3006493760-2025-00001
    Event Type
    Injury
    Date Received
    April 17, 2025
    Date of Event
    March 17, 2025
    Report Date
    April 17, 2025
    Manufacturer
    ICOTEC AG
    Product Code
    MQP
    UDI-DI
    07640164847412
    PMA / PMN Number
    K232790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATA RELATING TO MANUFACTURING DATE IS NOT ON THE LABEL AS UDI-PI. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE EXPANDABLE VBR AND THE PEDICLE SCREWS DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENT. INVESTIGATION OF HISTORICAL ADVERSE EVENT DATA DETERMINED THAT ICOTEC HAS NOT BECOME AWARE OF ANY SIMILAR EVENTS WITH THIS DEVICES TO DATE. THE RETRIEVED IMPLANTS HAVE BEEN INVESTIGATED IN OUR FACILITIES WITH THE FOLLOWING FINDINGS: IT IS ASSUMED THAT THE KONG-TL VBR WAS GRADUALLY COLLAPSING OVER TIME BECAUSE THE LOCKING SCREW WAS NOT PROPERLY PLACED AND THEREFORE WAS NOT ABLE TO PREVENT AXIAL MOVEMENT OF THE INTERNAL MECHANISM. THE GRADUAL COLLAPSE OF THE ANTERIOR SUPPORT MIGHT HAVE LED TO AN OVERLOAD OF THE POSTERIOR FIXATION WITH A SUBSEQUENT FRACTURE OF THE TWO PEDICLE SCREWS. BASED ON THE INFORMATION AVAILABLE, NO CORRECTIVE ACTIONS ARE PROPOSED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM AND AN ICOTEC EXPANDABLE VBR IN A SURGERY (B)(6) 2024). THE PATIENT NOTICED INCREASING PAIN. ON (B)(6) 2025, IT WAS DETECTED THAT THE VBR HAS COLLAPSED AND TWO PEDICLE SCREWS HAVE BROKEN. A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1681369 KONG-TL VBR E, EXPANDABLE BODY, STANDALONE, XS, Ø 19 MM X 22 - 29 MM KONG-TL VBR E, EXPANDABLE BODY, STANDALONE, XS, Ø 19 MM X 22 - 29 MM MQP ICOTEC AG 12-91-1922-9 24/01 07640164847412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention