BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF POSTERIOR POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X25X10 L5°

    MDR report key: 12519092 · Received September 23, 2021

    Report

    Report Number
    3005180920-2021-00770
    Event Type
    Injury
    Date Received
    September 23, 2021
    Date of Event
    August 27, 2021
    Report Date
    November 29, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831874
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON (B)(6) 2021: FEW MONTHS AFTER MULTILEVEL LUMBAR STABILIZATION SURGERY, A SUSPECTED INFECTION OCCURS AND SOME IMPLANTS ARE WITHDRAWN. OSTEOLYSIS HAS BEEN OBSERVED AROUND ONE OF THE POSTERIOR CAGES USED. THIS SAME OBSERVATION HAS BEEN REPORTED BY THIS SAME HOSPITAL PREVIOUSLY; THOUGH IT WAS NEVER REPORTED BY ANY OTHER HOSPITAL WORLDWIDE. A PECULIARITY OF THIS CASE IS THE USE OF A SINGLE PLIF CAGE ASSOCIATED WITH THE PEDICLE SCREW/ROD SYSTEM, BUT WE CANNOT ESTABLISH A RELATIONSHIP BETWEEN THIS FACTOR AND THE OBSERVED OSTEOLYSIS. IT'S ALSO POSSIBLE THAT OSTEOLYSIS AND INFECTION-MIMICKING SYMPTOMS ARE RELATED TO EACH OTHER, BUT AGAIN THIS CANNOT BE ESTABLISHED WITH THE INFORMATION AT HAND. IN ADDITION THE EVENT DESCRIPTION HAS BEEN UPDATED AS PER NEW INFO RECEIVED ON 21ST AND 22TH OCTOBER 2021.

    Additional Manufacturer Narrative · 0

    ON 04-NOV-2021 WE HAVE RECEIVED THE FOLLOWING INFORMATION: THE LOT OF THE FIRST CAGE WAS CONFIRMED. THE REVISION OF SEP 30TH WAS CONFIRMED TO BE DUE TO CAGE MIGRATION AND OSTEOLYSIS.

    Description of Event or Problem · 0

    AFTER A FEW WEEKS FROM THE PRIMARY SURGERY, A PEDICLE SCREW LOOSENING AND A CAGE MIGRATION IN L2/3 HAVE BEEN FOUND. ONE SINGLE PLIF CAGE WAS IMPLANTED. OSTEOLYSIS WAS FOUND AROUND THE POSTERIOR INTERBODY FUSION DEVICE. THERE WAS A SUSPICION OF INFECTION BUT IT WAS NOT CONFIRMED. ON (B)(6) 2021 THERE WAS AN EXTENDED FUSION FROM L2 TO S2AI, INCLUDING CEMENT AUGMENTATION IN L2, THE CAGE WAS REPLACED WITH A PLIF CAGE USED IN L2/3. ON (B)(6) , 2021 THERE WAS ANOTHER REVISION SURGERY WHERE THE CAGE IN L2/3 WAS REMOVED AND WAS REPLACED WITH AN XLIF CAGE.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 22-SEP-2021: LOT 1921806: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2020. EXPIRATION DATE: 2025-10-07. 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

    OSTEOLYSIS WAS FOUND AROUND THE POSTERIOR INTERBODY FUSION DEVICE, 3 MONTHS POST THE FIRST REVISION SURGERY. THE PATIENT WAS NOT REVISED YET. ONE SINGLE PLIF CAGE WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420574 MECTALIF POSTERIOR POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X25X10 L5° LUMBAR SPINE CAGE MAX MEDACTA INTERNATIONAL SA 03.27.045 1921806 07630030831874

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other