BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SR90D SCREW POLY-AXIAL 6.75 X 45MM

    MDR report key: 5551753 · Received April 6, 2016

    Report

    Report Number
    0009617544-2016-00139
    Event Type
    Injury
    Date Received
    April 6, 2016
    Date of Event
    February 16, 2016
    Report Date
    March 10, 2016
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    K992784
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER. CONCLUSION: THE ROOT CAUSE IS NOT DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT THE SURGERY, ON (B)(6) 2016, THE SURGEON FOUND THROUGH THE X-RAY THAT THE SCREW OF L3 LOOSENED AND PJK. THEREFORE, THE SURGEON REMOVED ALL SCREWS (L3-L5) AND THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6 THROUGH THE X-RAY THAT THE SCREW OF L3 LOOSENED AND PJK. THEREFORE, THE SURGEON REMOVED ALL SCREWS(L3-L5) AND THE PATIENT UNDERWENT THE REVISION SURGERY ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207683 SR90D SCREW POLY-AXIAL 6.75 X 45MM SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS. KWQ STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention