BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 5243002 · Received November 23, 2015

    Report

    Report Number
    0009617544-2015-00489
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 26, 2015
    Manufacturer
    STRYKER SPINE-US
    Product Code
    KWQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RISK ASSESSMENT. THE CUSTOMER REPORTED EVENT OF A DEVICE FRACTURE WAS CONFIRMED VIA THE CORRESPONDENCE. DEVICE NOT RETURNED, LOT NUMBER NOT PROVIDED. THE MOST LIKELY CAUSE OF THE CUSTOMER REPORTED EVENT IS FATIGUE FRACTURE DUE TO NON-FUSION OF THE VERTEBRAE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; ON (B)(6) 2013, PRIMARY PLF SURGERY WAS PERFORMED. AFTER THAT, THE BREAKAGE OF L5 LEFT SIDE SCREW WAS FOUND. AN EXTRACTION SURGERY IS PLANNED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; ON (B)(6) 2013, PRIMARY PLF SURGERY WAS PERFORMED. AFTER THAT, THE BREAKAGE OF L5 LEFT SIDE SCREW WAS FOUND. AN EXTRACTION SURGERY IS PLANNED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773781 UNKNOWN_SPINE_PRODUCT UNKNOWN SPINE PRODUCT KWQ STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention