BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED

    MDR report key: 15994328 · Received December 16, 2022

    Report

    Report Number
    3005180920-2022-00930
    Event Type
    Injury
    Date Received
    December 16, 2022
    Date of Event
    June 20, 2022
    Report Date
    December 16, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030875434
    PMA / PMN Number
    K160605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 15 DECEMBER 2022. LOT 1821427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2018. EXPIRATION DATE: 2023-SEP-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: 3 YEARS AFTER SINGLE LEVEL LUMBO-SACRAL STABILIZATION SURGERY A SCREW OF THE STANDALONE CAGE IS FOUND BROKEN. THIS CAN HAPPEN IF THE FUSION PROCESS DID NOT COMPLETE AFTER MORE THAN 12 MONTHS. POSTERIOR STABILIZATION WAS DEEMED APPROPRIATE. LONG TERM FRACTURE OF THE SCREWS IN CASE OF DELAYED FUSION IS A POSSIBLE ADVERSE EVENT, LISTED IN THE SAFETY DOCUMENTS OF THE PRODUCT. PRELIMINARY INVESTIGATION PERFORMED BY R&S SPINE DIRECTOR: DELAYED UNION IS HIGHLY LIKELY WHICH RESULT IN A FATIGUE FAILURE OF THE SCREW. ADDITIONAL ITEM INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 15 DECEMBER 2022. MECTALIF ANTERIOR 03.30.133 STAND-ALONE SCREW DIAM.5X35 ENHANCED (DOUBLE PACKAGING) (K160605) LOT. 1821409. LOT 1821409: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-AUG-2018. EXPIRATION DATE: 2023-AUG-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE SURGEON NOTED AFTER SURGERY THAT THE S1 SCREW HAD BROKEN. THE SURGEON THERE WAS NOT A COMPLETE FUSION ACROSS THE CAGE AND EVENTUALLY DECIDED TO FURTHER STABILIZE THE PATIENT WITH POSTERIOR FIXATION, ABOUT 3 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439669 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X35 ENHANCED ANTERIOR STAND-ALONE SCREW OVD MEDACTA INTERNATIONAL SA 03.30.133 1821427 07630030875434

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention