BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICOTEC VADER PEDICLE SYSTEM

    MDR report key: 15504553 · Received September 29, 2022

    Report

    Report Number
    3006493760-2022-00001
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    August 8, 2022
    Report Date
    September 28, 2022
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    PMA / PMN Number
    K200596
    Removal / Correction Number
    N.A.
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RELEVANT PRODUCTION RECORDS 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 EVENT WITH ITS PEDICLE SYSTEM TO DATE. THE SCREW DRIVERS WITH TORQUE LIMITING FUNCTION USED IN THE SURGERY FOR TIGHTENING THE NUT SCREWS WERE RETURNED TO ICOTEC. INVESTIGATION OF THE DEVICES SHOWED THAT THEY ARE WITHIN THEIR SPECIFICATION AND FUNCTION AS INTENDED. IT CAN THEREFORE BE CONCLUDED THAT THE SCREW DRIVERS WERE NOT THE CAUSE OF THE ADVERSE EVENT. ACCORDING TO OUR CURRENT KNOWLEDGE, THE EVENT HAS NOT RESULTED IN ANY ADVERSE POSTOPERATIVE HEALTH CONSEQUENCES FOR THE PATIENT.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH THE ICOTEC PEDICLE SYSTEM IN A FIRST SURGERY (B)(6) 2021). IN A SECOND SURGERY (B)(6) 2022) THE ICOTEC PEDICLE SYSTEM WAS EXTENDED DUE TO AN ADDITIONAL CORPECTOMY TREATMENT (VBR, NOT ICOTEC PRODUCT) . DURING A POST-OP CHECK AFTER THE SECOND SURGERY, IT WAS DETECTED THAT ONE NUT SCREW HAD COMPLETELY LOOSENED. A REVISION SURGERY HAD TO BE CARRIED OUT (B)(6) 2022). DURING THE REVISION, IT WAS REALIZED THAT SIX OF EIGHT NUT SCREWS HAD BECOME LOOSE. THE ICOTEC PEDICLE SYSTEM WAS REPLACED. DURING REPLACEMENT, ONE OF THE PEDICLE SCREWS OF THE FIRST SURGERY BROKE WHEN IT WAS UNSCREWED, DUE TO BONE INGROWTH. BROKEN PEDICLE SCREW COULD BE REMOVED COMPLETELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587925 ICOTEC VADER PEDICLE SYSTEM PEDICLE SCREW SYSTEM NKB ICOTEC AG 16-60-41000 VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention