BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIS CERVICAL CAGE SIZE H 6 MM L 14 MM

    MDR report key: 4964303 · Received August 4, 2015

    Report

    Report Number
    0009617544-2015-00352
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 9, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CAT#: 6741406, LOT#: 153354. METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: A MATERIALS ANALYSIS PERFORMED THE CAGE FRACTURED IN FAST PROPAGATION; THIS MEANS THAT FRACTURE WAS LIKELY CAUSED BY A SUDDEN IMPACT. THE CORRESPONDENCE INDICATES THAT THE CAGE WAS IMPACTED INTO THE DISC SPACE. THE INSTRUCTIONS FOR USE FOR THE SOLIS CAGE STATE THAT THE CAGE SHOULD NOT BE IMPACTED BECAUSE IMPACTION MAY LEAD TO BREAKAGE OF THE CAGE. MANUFACTURING RECORDS WERE REVIEWED FOR THE REPORTED LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. CONCLUSION: THE PLAUSIBLE ROOT CAUSE OF THE REPORTED EVENT IS A MISUSE - EXCESSIVE IMPACTION FORCE DURING CAGE INSERTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOLIS CAGE BROKE DURING EXPLANTATION. CUSTOMER GOT REPLACEMENT AND IMPLANTED ANOTHER CAGE. CAGE BROKE IN SEVERAL PARTS AND THAT铠WHY A PART NUMBER AND LOT CAN䔠BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SOLIS CAGE BROKE DURING EXPLANTATION. CUSTOMER GOT REPLACEMENT AND IMPLANTED ANOTHER CAGE. CAGE BROKE IN SEVERAL PARTS AND THAT铠WHY A PART NUMBER AND LOT CAN'T BE FORWARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509647 SOLIS CERVICAL CAGE SIZE H 6 MM L 14 MM INTERVERTEBRAL BODY FUSION DEVICE MAX STRYKER SPINE-FRANCE 153354

    Patients

    Seq Age Sex Outcome Treatment
    1