BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF OBLIQUE (TI PEEK) INTERBODY FUSION DEVICE 12X28X11 L10

    MDR report key: 9909845 · Received April 1, 2020

    Report

    Report Number
    3005180920-2020-00211
    Event Type
    Injury
    Date Received
    April 1, 2020
    Date of Event
    March 9, 2020
    Report Date
    April 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030830709
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 16 MARCH 2020: LOT 1820570: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2019. EXPIRATION DATE: 2024-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEWS PERFORMED ON 16 MARCH 2020: PEDICLE SCREW 03.50.029 PEDICLE SCREW 7X35 (K121115) LOT 1821270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JAN-2019. EXPIRATION DATE: 2024-01-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.029 PEDICLE SCREW 7X35 (K121115) LOT 1821500: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2019. EXPIRATION DATE: 2024-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    PLIF SURGERY WAS PERFORMED AT L3-L4, AND TLIF SURGERY WAS PERFORMED AT L4-L5. THE SURGEON INSERTED THE 6MM PEDICLE SCREWS AT L3-L4, AND THE 7MM PEDICLE SCREWS AT L5. THE SURGEON INSERTED THE 2 POSTERIOR CAGES TO L3/L4, AND THE OBLIQUE CAGE TO L4/L5. PATIENT BONE QUALITY WAS NORMAL. AFTER THE SURGERY, THE PATIENT ALLEGED A STRONG PAIN BECAUSE OF LOOSENING OF THE PEDICLE SCREWS AT L5 AND THE BACK OUT OF THE CAGE AT L4/L5. THE SURGEON REMOVED THE ROD AND THE BOTH SIDE OF PEDICLE SCREWS AT L5. THE SURGEON REMOVED THE OBLIQUE CAGE AND INSERTED THE NEW OBLIQUE CAGE AT L4-L5. THE SURGEON ALSO INSERTED THE 8MM X 40MM PEDICLE SCREW AT L5. THE SURGEON PERFORMED THE COMPRESSION AND ADD THE CROSS LINK. REVISION PERFORMED SUCCESSFULLY 19 DAYS AFTER PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375953 MECTALIF OBLIQUE (TI PEEK) INTERBODY FUSION DEVICE 12X28X11 L10 SPINE INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 03.26.051 1820570 07630030830709

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention