BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SWIFT 2-LEVEL ACP 38MM

    MDR report key: 2100720 · Received May 18, 2011

    Report

    Report Number
    1526439-2011-00079
    Event Type
    Injury
    Date Received
    May 18, 2011
    Manufacturer
    DEPUY SPINE INC.
    Product Code
    KWQ
    PMA / PMN Number
    K070994
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IN VIVO AND IMAGES WERE NOT PROVIDED FOR REVIEW. THE PROBLEM AS REPORTED CANNOT BE CONFIRMED. REVIEW OF RECORDS FOUND NO OTHER EVENT OF THIS NATURE HAS BEEN REPORTED OVER THE PAST 36-MONTHS. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    CONTACT REPORTS THAT A FOLLOW UP X-RAY SHOWED A CRACK IN THE SWIFT CERVICAL PLATE. PLATE WAS IMPLANTED ON (B)(6) AND IMAGE WAS TAKEN ON ROUTINE FOLLOW UP. THERE WAS NO ADVERSE OUTCOME REPORTED AS A RESULT OF THIS ISSUE AND NO ACTION HAS BEEN TAKEN. AS THIS COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWIFT 2-LEVEL ACP 38MM CERVICAL FIXATION DEVICE KWQ DEPUY SPINE INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention