BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 19256278 · Received May 6, 2024

    Report

    Report Number
    0009617544-2024-00075
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    June 14, 2016
    Report Date
    September 16, 2024
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 'THE NEGLIGIBLE INFLUENCE OF CHRONIC OBESITY ON HOSPITALIZATION, CLINICAL STATUS, AND COMPLICATIONS IN ELECTIVE POSTERIOR LUMBAR INTERBODY FUSION' IN INTERNATIONAL JOURNAL OF CHRONIC DISEASES VOLUME 2016, ARTICLE ID 2964625, WAS REVIEWED. IN THIS PROSPECTIVE STUDY, REGRESSION ANALYSIS WAS USED TO ANALYZE THE INFLUENCE OF THE BODY MASS INDEX (BMI) ON OPERATING TIME, POSTOPERATIVE CARE, HOSPITALIZATION TIME, TYPE OF POST-DISCHARGE CARE, CHANGE IN PARESIS OR SENSORY DEFICITS, PAIN LEVEL, WOUND COMPLICATIONS, CEREBROSPINAL FLUID LEAKAGE, AND IMPLANT COMPLICATIONS. THIS STUDY INCLUDED 78 PATIENTS OPERATED ON BETWEEN JUNE 2006 AND JUNE 2007 AND ALL PATIENTS WERE IMPLANTED WITH XIA POLYAXIAL SCREWS. ONE PATIENT EXPERIENCED POST-OPERATIVE, "DEVICE BREAKAGE," AND THREE PATIENTS EXPERIENCED RADIOLOGICAL SIGNS OF NON-FUSION AND DEVICE LOOSENING AFTER 12-MONTH FOLLOW-UP.

    Description of Event or Problem · 0

    THE ARTICLE 'THE NEGLIGIBLE INFLUENCE OF CHRONIC OBESITY ON HOSPITALIZATION, CLINICAL STATUS, AND COMPLICATIONS IN ELECTIVE POSTERIOR LUMBAR INTERBODY FUSION' IN INTERNATIONAL JOURNAL OF CHRONIC DISEASES VOLUME 2016, ARTICLE ID 2964625, WAS REVIEWED. IN THIS PROSPECTIVE STUDY, REGRESSION ANALYSIS WAS USED TO ANALYZE THE INFLUENCE OF THE BODY MASS INDEX (BMI) ON OPERATING TIME, POSTOPERATIVE CARE, HOSPITALIZATION TIME, TYPE OF POST-DISCHARGE CARE, CHANGE IN PARESIS OR SENSORY DEFICITS, PAIN LEVEL, WOUND COMPLICATIONS, CEREBROSPINAL FLUID LEAKAGE, AND IMPLANT COMPLICATIONS. THIS STUDY INCLUDED 78 PATIENTS OPERATED ON BETWEEN JUNE 2006 AND JUNE 2007 AND ALL PATIENTS WERE IMPLANTED WITH XIA POLYAXIAL SCREWS. ONE PATIENT EXPERIENCED POST-OPERATIVE, "DEVICE BREAKAGE," AND THREE PATIENTS EXPERIENCED RADIOLOGICAL SIGNS OF NON-FUSION AND DEVICE LOOSENING AFTER 12-MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381828 UNKNOWN_SPINE_PRODUCT THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention