BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3941192 · Received July 17, 2014

    Report

    Report Number
    0009617544-2014-00314
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; RESULTS: THE LOT # IS NOT KNOWN AND THE DEVICE WAS NOT RETURNED. MULTIPLE REQUESTS WERE MADE FOR THE RETURN OF THE DEVICE BUT IT WAS NOT RECEIVED. THE ESTABLISHED CAUSES OF THE EVENT ARE: FREEHAND USE DURING SCREW INSERTION, INSERTER LOOSENING DURING SURGERY, INSERTING NOT FULLY THREADING, USER UNFAMILIAR WITH SYSTEM, INTERACTION BETWEEN CAGE/SCREW/INSERTER, OUTER DIAMETER OF CLIP IS TOO LARGE, GENERAL USE ERROR. CONCLUSION: IN THIS CASE, IT WAS REPORTED THAT THE INSERTER GUIDE WAS USED WHILE IMPLANTING THE SCREWS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SCREWS PULLED FROM THE ANCHOR C SET HAD DAMAGED LOCKING RINGS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SCREWS PULLED FROM THE ANCHOR C SET HAD DAMAGED LOCKING RINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418992 UNKNOWN_SPINE_PRODUCT IMPLANT-SCREW KWP STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1