BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCHED (DOUBLE PACKAGING)

    MDR report key: 8084558 · Received November 19, 2018

    Report

    Report Number
    3005180920-2018-00916
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 19, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    OVD
    UDI-DI
    07630030875427
    PMA / PMN Number
    K160605
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 19 NOVEMBER 2018: LOT 1820441: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2018. EXPIRATION DATE: 2023-05-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    FROM THE FINAL PER-OP X-RAYS THE SURGEON DETECTED THAT THE PLATE WAS PROUD BY 1MM FROM THE ANTERIOR PORTION OF THE VERTEBRAL BODY. HE PROCEEDED TO USE THE FIXED STRAIGHT SCREW DRIVER TO BRING THE PLATE DOWN AND BY OVERNIGHTING THE SCREW, THE HEAD SHEARED OFF. THERE WERE NO FRAGMENTS, IT WAS A CLEAN BREAK. THE SCREW SHANK WAS LEFT IN PLACE, BURIED/COUNTERSUNK IN THE CAGE/BONE. THE BROKEN SCREW HEAD WAS REMOVED. NO DEFORMATION OR BREAKAGE OF THE INSTRUMENTS OCCURRED. THERE WERE A FIVE MINUTES OF DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927622 MECTALIF ANTERIOR STAND-ALONE SCREW DIAM.5X30 ENHANCHED (DOUBLE PACKAGING) SCREW OVD MEDACTA INTERNATIONAL SA 1820441 07630030875427

    Patients

    Seq Age Sex Outcome Treatment
    1 Other