BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3313103 · Received August 22, 2013

    Report

    Report Number
    3005739886-2013-00025
    Event Type
    Injury
    Date Received
    August 22, 2013
    Report Date
    July 23, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    KWQ
    PMA / PMN Number
    K060025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION WAS NOT POSSIBLE AS NO PRODUCT WAS RETURNED TO THE MANUFACTURER. LIMITED INFORMATION PROVIDED COULD NOT CONFIRM REVISION HAS BEEN PERFORMED. REVIEW OF RADIOGRAPHS PROVIDED WAS PERFORMED BY V.P. OF ENGINEERING ALONG WITH A MEDICAL PROFESSIONAL AND NOTED VERY EXCESSIVE SUBSIDENCE OF THE INTERBODY INTO THE ENDPLATE OF THE LOWEST VERTEBRAE OF THE CONSTRUCT. THE FULL ALLOWABLE ANGULATION OF THE CAUDAL BONE WAS REACHED AND EXCEEDED BY THIS EXTREME SUBSIDENCE, CAUSING THE SCREW TO PUSH OUT OF THE VERTEBRA AND INTO THE PLATE LOCKING RIVET. ALTHOUGH THE PART NUMBER IDENTITY OF THE SCREW COULD NOT BE DETERMINED, REVIEW OF COMPLAINT HISTORY FOR THE FIXED (SDF) AND VARIABLE (SDV) BONE SCREW FAMILIES USED WITH THE ACP PLATE SYSTEM DID NOT IDENTIFY A TREND OF SCREW BACKOUT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT PROCEDURE ON AN UNKNOWN DATE TO IMPLANT AN ANTERIOR CERVICAL PLATE AND SCREWS. SUBSEQUENT RADIOGRAPHS PERFORMED BY THE IMPLANTING SURGEON IDENTIFIED SCREW BACK OUT WITH FRACTURE OF THE LOCKING TAB OF THE ACP PLATE. PT IS NO LONGER BEING TREATED BY THIS DOCTOR. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408636 SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM BONE SCREW KWQ SPINAL USA, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R