BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 9886956 · Received March 26, 2020

    Report

    Report Number
    3004717358-2020-00001
    Event Type
    Malfunction
    Date Received
    March 26, 2020
    Date of Event
    February 18, 2020
    Report Date
    March 26, 2020
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    00193082057229
    PMA / PMN Number
    K150417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN DIAMETER 5.5MM Z-ROD WAS EXPLANTED DURING THE REVISION SURGERY AND REPLACED WITH A LARGER DIAMETER ROD (DIAMETER 6.0MM). THE EXPLANTED ROD WAS RETURNED TO SPINECRAFT FOR EVALUATION, WHICH ALLOWED US TO CONFIRM THE EXACT LOT NUMBER AND CONDUCT A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD. NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. COMPLAINT TREND ANALYSIS FOUND NO OTHER SIMILAR ISSUES TO HAVE BEEN REPORTED FOR DIAMETER 5.5MM OR DIAMETER 6.0MM TITANIUM Z-RODS. THE USAGE HISTORY REVIEW FOR THIS LOT SHOWED THAT 28 RODS OUT OF TOTAL OF (B)(4) MANUFACTURED HAVE BEEN USED IN SURGERIES TO DATE WITH NO ISSUES REPORTED. THE RETURNED PRODUCT WAS ALSO VISUALLY EVALUATED BUT NO CONCLUSIONS COULD BE MADE. ADDITIONALLY, PRE-OPERATIVE X-RAY IMAGES WERE RECEIVED AND REVIEWED; THE IMAGES SHOWED THAT NO BONY FUSION IS EVIDENT AT THE LEVEL WHERE THIS Z-ROD WAS USED. BASED ON THE ABOVE INFORMATION COLLECTED AND REVIEWED, IT HAS BEEN CONCLUDED THAT THIS ROD BREAKAGE LIKELY OCCURRED DUE TO NON-UNION AND CYCLICAL LOADING OVER TIME. THIS IS A KNOWN INHERENT RISK ASSOCIATED WITH METALLIC IMPLANTS WHERE IF BONY FUSION IS DELAYED, OR DOES NOT OCCUR, THE IMPLANT MAY EVENTUALLY BREAK DUE TO METAL FATIGUE. AND THIS RISK IS SPECIFIED IN OUR INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, FROM THE INVESTIGATION IT HAS BEEN IDENTIFIED THAT THERE HAS BEEN NO ISSUE IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED.

    Description of Event or Problem · 1

    APPROXIMATELY 16 MONTHS POST-OPERATIVELY, THE PATIENT WAS REVISED FOR A BROKEN DIAMETER 5.5MM TITANIUM Z-ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348864 ASTRA SPINE SYSTEM ROD NKB SPINECRAFT 112980 00193082057229

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention