BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 20694487 · Received November 15, 2024

    Report

    Report Number
    0009617544-2024-00168
    Event Type
    Injury
    Date Received
    November 15, 2024
    Date of Event
    August 6, 2020
    Report Date
    March 24, 2025
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G1. H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE ARTICLE 'LONG-TERM RADIOGRAPHIC OUTCOME OF OCCIPITOCERVICAL FIXATION' IN SPINE JOURNAL VOLUME 46, NUMBER 3, PP 152¿159 WAS REVIEWED. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE LONGTERM RADIOGRAPHIC OUTCOME OF PATIENTS WHO UNDERWENT OCCIPITOCERVICAL FIXATION (OCF) USING A MODERN SCREW/ROD SYSTEM. WE RETROSPECTIVELY REVIEWED 22 PATIENTS WHO UNDERWENT OCF WITH AN OASYS SCREW-BASED CONSTRUCT. FUSION STATUS WAS EVALUATED ON THE CT SCAN AT THE FINAL FOLLOWUP. THE RADIOGRAPHIC EVALUATION WAS PERFORMED BASED ON LATERAL RADIOGRAPHS IN THE SITTING POSITION PREOPERATIVELY, IMMEDIATELY POSTOPERATIVE (FIRST OUTPATIENT VISIT), AND AT THE FINAL FOLLOW-UP (FU). THE MEAN AGE WAS 62.1-16.8 YEARS. PREOPERATIVE DIAGNOSIS INCLUDED OC INSTABILITY DUE TO RHEUMATOID ARTHRITIS (N=11), DEGENERATIVE OSTEOARTHRITIS WITH OR WITHOUT CONGENITAL ANOMALY (KLIPPEL FILE SYNDROME) (N=7 AND 2, RESPECTIVELY), TRAUMATIC ODONTOID FRACTURE (N=1), AND METASTATIC TUMOR INVASION (N=1). ONE PATIENT WAS REVISED TO ADDRESS A FRACTURED SCREW.

    Description of Event or Problem · 0

    THE ARTICLE 'LONG-TERM RADIOGRAPHIC OUTCOME OF OCCIPITOCERVICAL FIXATION' IN SPINE JOURNAL VOLUME 46, NUMBER 3, PP 152¿159 WAS REVIEWED. THE AIM OF THIS STUDY WAS TO INVESTIGATE THE LONGTERM RADIOGRAPHIC OUTCOME OF PATIENTS WHO UNDERWENT OCCIPITOCERVICAL FIXATION (OCF) USING A MODERN SCREW/ROD SYSTEM. WE RETROSPECTIVELY REVIEWED 22 PATIENTS WHO UNDERWENT OCF WITH AN OASYS SCREW-BASED CONSTRUCT. FUSION STATUS WAS EVALUATED ON THE CT SCAN AT THE FINAL FOLLOWUP. THE RADIOGRAPHIC EVALUATION WAS PERFORMED BASED ON LATERAL RADIOGRAPHS IN THE SITTING POSITION PREOPERATIVELY, IMMEDIATELY POSTOPERATIVE (FIRST OUTPATIENT VISIT), AND AT THE FINAL FOLLOW-UP (FU). THE MEAN AGE WAS 62.1-16.8 YEARS. PREOPERATIVE DIAGNOSIS INCLUDED OC INSTABILITY DUE TO RHEUMATOID ARTHRITIS (N=11), DEGENERATIVE OSTEOARTHRITIS WITH OR WITHOUT CONGENITAL ANOMALY (KLIPPEL FILE SYNDROME) (N=7 AND 2, RESPECTIVELY), TRAUMATIC ODONTOID FRACTURE (N=1), AND METASTATIC TUMOR INVASION (N=1). ONE PATIENT WAS REVISED TO ADDRESS A FRACTURED SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56364 UNKNOWN_SPINE_PRODUCT POSTERIOR CERVICAL SCREW SYSTEM NKG STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention