BEUDAMED
    FDA Adverse Event Other Summary report: N

    POLYAXIAL SCREW-FENESTRATED 6.5X45MM

    MDR report key: 2222850 · Received August 9, 2011

    Report

    Report Number
    3008657535-2011-00032
    Event Type
    Other
    Date Received
    August 9, 2011
    Date of Event
    July 20, 2011
    Report Date
    August 9, 2011
    Manufacturer
    INTEGRA, MEDINA
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT A PT WHO HAD SPINAL SURGERY USING THE CORAL SPINAL SYSTEM FUSION IMPLANT SYSTEM (USED FOR THE CORRECTION AND STABILIZATION OF THE LUMBAR OR LOWER REGION OF THE SPINE), PRESENTED AT A POSTOPERATIVE VISIT WITH A COMPLAINT OF PAIN. X-RAYS SHOWED THAT POLYAXIAL SCREWS HAD SEPARATION OF THE SCREW HEAD FROM THE SCREW AT VERTEBRAL LEVEL L5 AND THE SACRUM. INTEGRA HAS REQUESTED ADDITIONAL CLINICAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYAXIAL SCREW-FENESTRATED 6.5X45MM CORAL MIS KWQ INTEGRA, MEDINA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other