BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 6296252 · Received February 2, 2017

    Report

    Report Number
    0009617544-2017-00041
    Event Type
    Injury
    Date Received
    February 2, 2017
    Date of Event
    January 6, 2017
    Report Date
    June 1, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: RISK ASSESSMENT; RESULT: NO LOT # WAS PROVIDED, SO A MANUFACTURING RECORD REVIEW COULD NOT BE PERFORMED. THE PRODUCT IS NOT AVAILABLE FOR INSPECTION. CONCLUSION: THE FAILURE MODE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY FOR TH10-L1(PLF). ON (B)(6) 2016, THE PATIENT UNDERWENT THE REVISION SURGERY FOR L2-3(PLIF). AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE SCREW BROKE. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY NOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT UNDERWENT THE SURGERY FOR TH10-L1(PLF). ON (B)(6) 2016, THE PATIENT UNDERWENT THE REVISION SURGERY FOR L2-3(PLIF). AFTER SURGERY, WHEN THE SURGEON CHECKED X-RAY, THE SCREW BROKE. THEREFORE, THE SURGEON PLANNING THE REVISION SURGERY NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81950 UNKNOWN_SPINE_PRODUCT UNKNOWN SPINE PRODUCT KWP STRYKER SPINE-FRANCE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention