BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX ANTERIOR CERVICAL PLATE

    MDR report key: 2438557 · Received January 13, 2012

    Report

    Report Number
    3004485144-2012-00002
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Date of Event
    June 2, 2011
    Report Date
    January 6, 2012
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INJURY REPORTED IN THIS SPECIFIC EVENT. EVENT CONSIDERED MDR REPORTABLE AS PATIENT INJURY IS POSSIBLE IF EVENT WERE TO RECUR. NO REVISION SURGERY PERFORMED. FEEDBACK FROM SURGEON INDICATED THAT SURGERY IS NOT RECOMMENDED AT THIS TIME AS THE PATIENT HAS NOT SHOWN ANY UNUSUAL SYMPTOMS OR PAIN. DISCUSSION WITH SALES REPRESENTATIVE ON (B)(4) 2012 INDICATED THAT EVENT MAY BE EXPLAINED DUE TO LIMITED SCREW PURCHASE WITHIN THE BONE DUE TO POOR BONE QUALITY; HOWEVER THE CAUSE REMAINS UNKNOWN. THE IFU INDICATES POOR BONE QUALITY AS A CONTRAINDICATION AS WELL AS LOOSENING OR MOVEMENT/MIGRATION AS A POSSIBLE COMPLICATION.

    Description of Event or Problem · 1

    AN ANTERIOR CERVICAL PLATE BACKED AWAY FROM THE VERTEBRAE. REVIEW OF X-RAY FILMS INDICATED THAT THE SELF-DRILLING SCREWS AND LOCKING CAPS APPEARED SECURELY IN PLACE WITH THE CERVICAL PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX ANTERIOR CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ LANX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1