BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIS CERVICAL CAGE SIZE H 5 MM L 12 MM

    MDR report key: 3940234 · Received July 17, 2014

    Report

    Report Number
    0009617544-2014-00312
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT;RESULTS: NO RELEVANT ISSUES WERE FOUND IN THE MANUFACTURING RECORDS OF THE DEVICE LOT THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT IS A MISUSE - EXCESSIVE IMPACTION FORCE DURING CAGE INSERTION. THIS CAUSE WAS CONFIRMED BY A MATERIALS ANALYSIS WHICH CONCLUDED THAT THE DEVICE FRACTURED IN FAST PROPAGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE CERVICAL CAGE WAS BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE CERVICAL CAGE WITHOUT ANY COMPLICATION OR SURGERY DELAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE SURGERY THE CERVICAL CAGE WAS BROKEN. THE SURGEON WAS ABLE TO RETRIEVE THE CERVICAL CAGE WITHOUT ANY COMPLICATION OR SURGERY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418125 SOLIS CERVICAL CAGE SIZE H 5 MM L 12 MM IMPLANT-SPACER MAX STRYKER SPINE-FRANCE 144749

    Patients

    Seq Age Sex Outcome Treatment
    1