BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 19215935 · Received April 30, 2024

    Report

    Report Number
    0009617544-2024-00059
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    November 9, 2019
    Report Date
    August 22, 2024
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE ARTICLE 'MEASURING THE PERFORMANCE OF PATIENT-SPECIFIC SOLUTIONS FOR MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY' IN JOURNAL OF CLINICAL NEUROSCIENCE 71 (2020) 43¿50, WAS REVIEWED. ONE HUNDRED TWENTY-NINE CONSECUTIVE PATIENTS SCHEDULED FOR MIS TLIF SURGERY WERE INCLUDED IN THIS STUDY AND CUSTOMISED "BIOMODELS" WERE MADE FOR EACH PATIENT TO ASSIST WITH PLANNING THE INSTRUMENTATION. CUSTOMIZED TOOL KITS INCLUDED A SKIN-SURFACE STEREOTACTIC JAMSHIDI GUIDE, SOFT-TISSUE DILATOR INSERTS, A TUBULAR RETRACTOR, AND AN OSTEOTOMY GUIDE. PATIENTS WERE IMPLANTED WITH EITHER THE ES2 OR THE RTI (NON-STRYKER) PEDICLE SCREW SYSTEMS AS WELL AS RTI OR EIT (NON-STRYKER) LORDOTIC CAGES. THREE PATIENTS UNDERWENT REVISION SURGERY TO ADDRESS SCREW POSITIONING.

    Description of Event or Problem · 0

    THE ARTICLE 'MEASURING THE PERFORMANCE OF PATIENT-SPECIFIC SOLUTIONS FOR MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION SURGERY' IN JOURNAL OF CLINICAL NEUROSCIENCE 71 (2020) 43¿50, WAS REVIEWED. (B)(4) CONSECUTIVE PATIENTS SCHEDULED FOR MIS TLIF SURGERY WERE INCLUDED IN THIS STUDY AND CUSTOMISED "BIOMODELS" WERE MADE FOR EACH PATIENT TO ASSIST WITH PLANNING THE INSTRUMENTATION. CUSTOMIZED TOOL KITS INCLUDED A SKIN-SURFACE STEREOTACTIC JAMSHIDI GUIDE, SOFT-TISSUE DILATOR INSERTS, A TUBULAR RETRACTOR, AND AN OSTEOTOMY GUIDE. PATIENTS WERE IMPLANTED WITH EITHER THE ES2 OR THE RTI (NON-STRYKER) PEDICLE SCREW SYSTEMS AS WELL AS RTI OR EIT (NON-STRYKER) LORDOTIC CAGES. THREE PATIENTS UNDERWENT REVISION SURGERY TO ADDRESS SCREW POSITIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2068134 UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention