BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIPLATE SELF DRILLING SCREW, 12MM

    MDR report key: 1012350 · Received February 12, 2008

    Report

    Report Number
    1526439-2008-00064
    Event Type
    Injury
    Date Received
    February 12, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K042544
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSION CAN BE MADE AT THIS TIME. VISUAL EXAMINATION OF IMAGES INDICATES THAT ANGLE OF INSERTION MAY HAVE BEEN A CONTRIBUTING FACTOR.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT HE PERFORMED CERVICAL FIXATION WITH UNIPLATE IN EARLY NOV. THE PATIENT FUSED AND IS ASYMPTOMATIC, HOWEVER, ONE MONTH FOLLOW UP CONFIRMED SCREW BACKOUT. SURGEON STATES THAT IF IT PROGRESSES FURTHER HE WILL REVISE TO REMOVE THE SCREW. AS THIS MAY RESULT IN THE NEED FOR SURGICAL INTERVENTION AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIPLATE SELF DRILLING SCREW, 12MM CERVICAL FIXATION DEVICE KWQ DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention UNIPLATE