BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDER CERVICAL PLATING SYSTEM

    MDR report key: 2583289 · Received May 18, 2012

    Report

    Report Number
    3005031160-2012-00007
    Event Type
    Injury
    Date Received
    May 18, 2012
    Report Date
    May 18, 2012
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: CERVICAL FUSION. ACCORDING TO THE REPORTER, A SCREW BROKE SIX-MONTHS POST-OPERATIVELY. NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDER CERVICAL PLATING SYSTEM CERVICAL PLATING SYSTEM KWQ X-SPINE SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1