BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUVASIVE RELINE SYSTEM

    MDR report key: 20920350 · Received December 12, 2024

    Report

    Report Number
    2031966-2024-00341
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    July 2, 2024
    Report Date
    December 12, 2024
    Manufacturer
    NUVASIVE INC.
    Product Code
    NKB
    PMA / PMN Number
    K223181
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE MALFUNCTION ALLEGED. NO DEVICE INFORMATION PROVIDED SO THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE REPORTED EVENT NOTED THE PATIENT INCURRED A 1MM PERFORATION OF THE DURA TOOK PLACE WITHOUT A REPORTED DEVICE PROBLEM INDICATING AN INCIDENTAL SURGICAL ERROR TOOK PLACE AND UNRELATED TO NUVASIVE DEVICE FUNCTIONALITY. NO ADDITIONAL INVESTIGATION REQUIRED. LABELING REVIEW: "RESIDUAL RISKS AND POTENTIAL SIDE EFFECTS AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY..." "RESIDUAL RISKS TO THE PATIENT ASSOCIATED WITH USE OF GENERAL SURGICAL INSTRUMENTS ARE...RISKS INHERENT TO INVASIVE SURGICAL PROCEDURES ASSOCIATED WITH SITE ACCESS AND PREPARATION WHICH CANNOT BE ELIMINATED. THESE RISKS INCLUDE...VASCULAR INJURY, AND DURAL TEAR (WITH THE POTENTIAL FOR CEREBROSPINAL FLUID LEAKAGE); MANY OF THESE EVENTS MAY NECESSITATE REVISION SURGERY..." "PRE-OPERATIVE WARNINGS THE METHOD OF USE FOR THE INSTRUMENTS ARE TO BE DETERMINED BY THE USER¿S EXPERIENCE AND TRAINING IN SURGICAL PROCEDURES. SOME INSTRUMENTS MAY BE USED IN CONJUNCTION WITH OTHER NUVASIVE DEVICES. REFER TO THE INSTRUCTIONS FOR USE FOR THESE DEVICES FOR IMPORTANT LABELING INFORMATION. DO NOT USE THESE INSTRUMENTS FOR ANY ACTION FOR WHICH IT WAS NOT INTENDED SUCH AS HAMMERING, PRYING, OR LIFTING...." "...CARE SHOULD BE USED DURING SURGICAL PROCEDURES TO PREVENT DAMAGE TO THE DEVICE(S) AND INJURY TO THE PATIENT..." "INTRA-OPERATIVE WARNINGS THE PHYSICIAN SHOULD TAKE PRECAUTIONS AGAINST PUTTING UNDUE STRESS ON THE SPINAL AREA WITH INSTRUMENTS. ANY SURGICAL TECHNIQUE SHOULD BE CAREFULLY FOLLOWED. IT IS IMPORTANT THAT THE SURGEON EXERCISE EXTREME CAUTION WHEN WORKING IN CLOSE PROXIMITY TO VITAL ORGANS, NERVES, OR VESSELS, AND THAT THE FORCE APPLIED TO THE INSTRUMENTATION IS NOT EXCESSIVE, TO PREVENT POTENTIAL INJURY TO THE PATIENT. OVER-BENDING, NOTCHING, STRIKING, AND/OR SCRATCHING OF IMPLANTS WITH ANY INSTRUMENT SHOULD BE AVOIDED TO REDUCE THE RISK OF BREAKAGE...." "METHOD OF USE IF THERE IS ANY DOUBT OR UNCERTAINTY CONCERNING THE PROPER USE OF INSTRUMENTS, PLEASE CONTACT NUVASIVE CUSTOMER SERVICE. ANY AVAILABLE SURGICAL TECHNIQUES WILL BE PROVIDED UPON REQUEST. FOR OPTIMAL RESULTS, THE SAME TYPE OF INSTRUMENTS USED FOR IMPLANTATION SHOULD BE USED FOR IMPLANT REMOVAL..." "INFORMATION TO OBTAIN A SURGICAL TECHNIQUE MANUAL OR OTHER APPLICABLE INSTRUCTIONS FOR USE OR SHOULD ANY INFORMATION REGARDING THE PRODUCTS OR THEIR USES BE REQUIRED, PLEASE CONTACT YOUR LOCAL REPRESENTATIVE OR NUVASIVE DIRECTLY AT..." 9004421-EN W-2022-12.

    Description of Event or Problem · 0

    THE EVENT WAS IDENTIFIED DURING A REVIEW OF THE POSTERIOR CERVICAL FUSION (PCF) STUDY, THE REPORT IDENTIFIED THAT ON (B)(6) 2024 A PATIENT UNDERWENT A PCF AT C3-T2 DURING WHICH A SMALL 1MM PIN HOLE IN THE DUROTOMY TOOK PLACE FOLLOWED BY DURAGEN PLUS PATCH AND VISTASEAL. NO ADDITIONAL PROBLEMS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1905337 NUVASIVE RELINE SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NUVASIVE INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention