BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 7.5 × 45 MM

    MDR report key: 21958276 · Received May 5, 2025

    Report

    Report Number
    3006493760-2025-00002
    Event Type
    Injury
    Date Received
    May 5, 2025
    Date of Event
    April 4, 2025
    Report Date
    May 2, 2025
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    UDI-DI
    07640164844817
    PMA / PMN Number
    K232628
    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. NO INFORMATION REGARDING A POTENTIAL CAUSE HAS BEEN RECEIVED FROM THE HEALTH PROFESSIONAL. ANALYSIS OF THE RELEVANT PRODUCTION RECORDS OF THE PEDICLE SCREW DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENT. THE EVALUATION OF THE RETURNED PEDICLE SCREW IS STILL ONGOING. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION OF THE CAUSE OF THIS EVENT. 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 IN A SURGERY ((B)(6) 2023). THE PATIENT NOTICED INCREASING PAIN. ON (B)(6) 2025 IT WAS DETECTED THAT ONE PEDICLE SCREW HAS BROKEN. A REVISION SURGERY (DATE NOT REPORTED) WAS PERFORMED AND THE IMPLANTS HAVE BEEN REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485556 VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 7.5 × 45 MM VADER® PEDICLE SYSTEM SCREW, CARBON/PEEK, POLYAX., FEN. Ø 7.5 × 45 MM NKB ICOTEC AG 16-6022-57545 23/02 07640164844817

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention