BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X)

    MDR report key: 7582505 · Received June 8, 2018

    Report

    Report Number
    3005180920-2018-00409
    Event Type
    Injury
    Date Received
    June 8, 2018
    Date of Event
    May 16, 2018
    Report Date
    July 10, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030840333
    PMA / PMN Number
    K140361
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DIRECTOR ON 11 JUNE 2018: REVISION SURGERY OCCURRED 3 YEARS AFTER PRIMARY PROCEDURE DUE TO PSEUDARTHROSIS. INCOMPLETE FUSION IS A POSSIBLE ADVERSE EVENTS AND MAY BE DUE TO DIFFERENT FACTORS EITHER MECHANICAL OR PATIENT RELATED. ON THE BASIS OF THE INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE WHEN THE SCREW BREAKAGE OCCURRED AND ITS RELATION WITH PSEUDOARTHROSIS.

    Additional Manufacturer Narrative · 1

    THREE PIECES OF THE LOT 141356 AND A PIECE OF THE LOT 141188 REFERENCE 03.70.240 (K140361); CERVICAL PLATE L2X40MM WERE REMOVED DUE TO LEFT ARM AND NECK PAIN 3 YEARS AND 3 MONTHS AFTER PRIMARY. THE PATIENT HAS PSEUDOARTHROSIS. A PIECE OF THE LOT 141356 WAS FOUND BROKEN BY THE SURGEON. BATCH REVIEW PERFORMED ON 05 JUNE 2018; LOT 141356: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2014 EXPIRATION DATE: 2019-08-31 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

    THE PATIENT CAME IN COMPLAINING OF LEFT ARM AND NECK PAIN 3 YEARS AND 3 MONTHS AFTER PRIMARY. THE PATIENT HAS PSEUDOARTHROSIS. THE SURGEON REMOVED MEDACTA SCREWS AND 1 PLATE. ONE SCREW COULD HAVE NOT BEEN REMOVED AS THE HEAD WAS FOUND BROKEN DURING REVISION. THE SURGEON WAS ABLE TO RECOVER THE HEAD OF THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425546 CERVICAL PLATE VARIABLE SELF-TAPPING SCREW DIAM. 4X14MM (2X) VARIABLE SELF-TAPPING SCREW KWQ MEDACTA INTERNATIONAL SA 141356 07630030840333

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention