BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40

    MDR report key: 9659907 · Received February 3, 2020

    Report

    Report Number
    3005180920-2020-00020
    Event Type
    Injury
    Date Received
    February 3, 2020
    Date of Event
    January 7, 2020
    Report Date
    February 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834288
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 09 JANUARY 2020. LOT 1820669: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2018. EXPIRATION DATE: 2023-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. TWO EQUAL DEVICES WERE REPORTED IN THIS COMPLAINT. ADDITIONAL IMPLANT INVOLVED IN THE COMPLAINT, BATCH REVIEW PERFORMED ON (B)(6) 2020. MECTALIF POSTERIOR (TI PEEK) 03.27.029 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X22X8 L0° (K133192) LOT. 1721093. LOT 1721093: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAY-2018. EXPIRATION DATE: 2023-05-06. 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

    PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. PLIF SURGERY WAS PERFORMED AT L4-S2AI. REVISION SURGERY WAS PERFORMED AT L5 DUE TO THE LOOSENING OF THE PEDICLE SCREWS AND NONE BONE FUSION OF THE CAGE ALMOST 1 YEAR AFTER THE PRIMARY. THE SURGEON REPLACED WITH NEW PEDICLE SCREWS AND CAGE. PRIMARY AND REVISION SURGERY PERFORMED AS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120765 PEDICLE SCREW 03.50.030 PEDICLE SCREW 7X40 PEDICLE SCREW 7X40 KWP MEDACTA INTERNATIONAL SA 03.50.030 1820669 07630030834288

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention