BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICOTEC VADER PEDICLE SYSTEM S-ROD, CARBON/PEEK, MULTI CURVED

    MDR report key: 20168827 · Received September 9, 2024

    Report

    Report Number
    20168827
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    December 23, 2023
    Report Date
    February 9, 2024
    Manufacturer
    ICOTEC AG
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT UNDERWENT STAGE 1 L2 EN BLOC CHORDOMA RESECTION, T11-L5 REVISION POSTERIOR SPINAL INSTRUMENTATION WITH CARBON FIBER, L1-L3 LAMINECTOMIES, FACETECTOMIES, RETROPERITONEAL DISSECTION, AND LEFT L2 RHIZOTOMY. PATIENT DISCHARGED FROM THE FACILITY WITH NO NOTED ISSUES. WHILE AT HOME 48 DAYS LATER, THE PATIENT WENT TO STAND AFTER USING THE RESTROOM AND FELT A POP AND SHARP PAIN IN HER BACK. PATIENT PRESENTED TO THE HOSPITAL AND IMAGING WAS OBTAINED. THE COMPUTED TOMOGRAPHY (CT) DEMONSTRATED BILATERAL ROD FRACTURE DIRECTLY BELOW THE L1 PEDICLE SCREW WITH CORONAL TRANSLATION SECONDARY TO THE ROD FRACTURE. PATIENT WAS TAKEN TO THE OPERATING ROOM AND UNDERWENT REVISION OF THE T11-L5 POSTERIOR SPINAL INSTRUMENTED FUSION.

    Description of Event or Problem · 0

    PATIENT UNDERWENT STAGE 1 L2 EN BLOC CHORDOMA RESECTION, T11-L5 REVISION POSTERIOR SPINAL INSTRUMENTATION WITH CARBON FIBER, L1-L3 LAMINECTOMIES, FACETECTOMIES, RETROPERITONEAL DISSECTION, AND LEFT L2 RHIZOTOMY. PATIENT DISCHARGED FROM THE FACILITY WITH NO NOTED ISSUES. WHILE AT HOME 48 DAYS LATER, THE PATIENT WENT TO STAND AFTER USING THE RESTROOM AND FELT A POP AND SHARP PAIN IN HER BACK. PATIENT PRESENTED TO THE HOSPITAL AND IMAGING WAS OBTAINED. THE COMPUTED TOMOGRAPHY (CT) DEMONSTRATED BILATERAL ROD FRACTURE DIRECTLY BELOW THE L1 PEDICLE SCREW WITH CORONAL TRANSLATION SECONDARY TO THE ROD FRACTURE. PATIENT WAS TAKEN TO THE OPERATING ROOM AND UNDERWENT REVISION OF THE T11-L5 POSTERIOR SPINAL INSTRUMENTED FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562534 ICOTEC VADER PEDICLE SYSTEM S-ROD, CARBON/PEEK, MULTI CURVED THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ICOTEC AG

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female Required Intervention| H| O