BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X)

    MDR report key: 12473832 · Received September 15, 2021

    Report

    Report Number
    3005180920-2021-00754
    Event Type
    Malfunction
    Date Received
    September 15, 2021
    Date of Event
    August 11, 2021
    Report Date
    November 9, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030841361
    PMA / PMN Number
    K140361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATON: IN A 4-LEVEL CERVICAL STABILIZATION CONSTRUCT, FEW MONTHS AFTER SURGERY ONE SCREW (RIGHT AT C7) BROKE, AND SOON AFTER ALSO BOTH SCREWS IMPLANTED AT C6 ARE FOUND BROKEN. SCREW BREAKAGES ARE A POSSIBLE ADVERSE EVENT, DESCRIBED IN LITERATURE; THE EVENT USUALLY TAKES PLACE WHEN FUSION IS NOT ACHIEVED. TO DATE, THERE ARE NO CLUES THAT MAY LEAD TO THINK OF A DEFECTIVE DEVICE. ADDITIONAL SURGERY WAS UNDERTAKEN TO GIVE FURTHER STABILITY AND A 360° APPROACH WAS CHOSEN. PRELIMINARY INVESTIGATION PERFORMED BY SPINE R&D DIRECTOR AS REPORTED IN THE LITERATURE SCREW BREAKAGES IN THE CERVICAL SPINE (PLATES) CAN OCCUR AMONG OTHERS IN CASE OF INSTABILITY, IN SOME OF THESE CASES ADDITIONAL FIXATION E.G, WITH POSTERIOR INSTRUMENTATION IS REQUIRED TO ACHIEVE THE STABILITY REQUIRED FOR FUSION.

    Description of Event or Problem · 0

    AT 3 MONTHS AFTER THE PRIMARY SURGERY, THE C7 SCREW ON THE RIGHT SIDE IS BROKEN, AND ADDITIONALLY, IT IS SUSPECTED THAT THE SCREW ON THE LEFT SIDE IS LOOSE. THE PATIENT WAS IN AN ASYMPTOMATIC CONDITION, THEREFORE NO REVISION SURGERY WAS PLANNED INITIALLY. ONE MONTH AFTER, OTHER SCREWS HAD BROKEN (IN C6 LEVEL). ON (B)(6) 2021, 4 MONTHS AFTER THE PRIMARY SURGERY, ADDITIONAL SURGERY WAS PERFORMED. IN TOTAL, FOUR SCREWS WERE FOUND BROKEN (C6 AND C7 LEVELS ON BOTH SIDES). NO IMPLANTS HAVE BEEN REVISED AS THE PATIENT WAS IN AN ASYMPTOMATIC CONDITION. TO STOP ADDITIONAL SCREW LOOSENING OR BREAKING, A 360° FIXATION WAS TAKEN.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11 SEPT 2021: LOT 1921601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2019. EXPIRATION DATE: 2024-OCT-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ANOTHER DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 11 SEPT 2021: CERVICAL PLATE 03.70.277 FIXED SELF-TAPPING SCREW DIAM. 4X16MM (2X) (K140361) LOT 1920104: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-NOV-2019. EXPIRATION DATE: 2024-OCT-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CERVICAL PLATE 03.70.264 FIXED SELF-TAPPING SCREW DIAM. 4X16MM (1X) (K140361) LOT 141341A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEPT-2019. EXPIRATION DATE: 2024-AUG-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CERVICAL PLATE 03.70.277 FIXED SELF-TAPPING SCREW DIAM. 4X16MM (2X) (K140361) LOT 1921587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2019. EXPIRATION DATE: 2024-OCT-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    3 MONTHS AFTER THE PRIMARY SURGERY THE C7 SCREW ON THE RIGHT SIDE IS BROKEN, AND ADDITIONALLY, IT IS SUSPECTED THAT THE SCREW ON THE LEFT SIDE IS LOOSED. THE PATIENT WAS IN AN ASYMPTOMATIC CONDITION, THEREFORE NO REVISION SURGERY WAS PLANNED INITIALLY. ONE MONTH AFTER, OTHER SCREWS HAD BROKEN (IN C6 LEVEL), AND THE REVISION SURGERY WAS PLANNED. IT IS UNKNOWN HOW MANY SCREWS ARE BROKEN AT THIS MOMENT AND WHETHER BROKEN SCREWS WILL BE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1376175 CERVICAL PLATE FIXED SELF-TAPPING SCREW DIAM. 4X18MM (2X) SPINE SELF-TAPPING SCREW KWQ MEDACTA INTERNATIONAL SA 03.70.279 1921601 07630030841361

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other| R