BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW

    MDR report key: 3102656 · Received May 9, 2013

    Report

    Report Number
    0009617544-2013-00174
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWP
    PMA / PMN Number
    K040261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT. RESULTS: THE CUSTOMER REPORTED EVENT OF WEAR ON A REFLEX HYBRID VARIABLE ANGLE SELF-DRILLING SCREW WAS CONFIRMED VIA A VISUAL EVALUATION. THE CORRESPONDENCE INDICATED THAT THE INSERTION DIRECTION OF THE SCREW WAS DISPLACED; THEREFORE, THE SCREW WAS NOT INSERTED USING THE CORRECT TRAJECTORY. MANUFACTURING RECORDS WERE REVIEWED, BUT NO ANOMALIES WERE FOUND. CONCLUSION: SINCE THE SCREW WAS NOT INSERTED FOLLOWING THE CORRECT TRAJECTORY, WE CAN CONCLUDE THAT THE CAUSE OF THE MATERIAL WEAR WAS DUE TO THE IMPROPER INSERTION OF THE SCREW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING REFLEX UG SURGERY, INSERTION DIRECTION OF THE SCREW IS DISPLACED. THE SURGEON EXTRACTED THE SCREW AND CONFIRMED IT, THE THREAD OF THE SCREW WAS WORN. HE USED OTHER NEW SCREW AND FINISHED THE SURGERY."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "DURING REFLEX UG SURGERY, INSERTION DIRECTION OF THE SCREW IS DISPLACED. THE SURGEON EXTRACTED THE SCREW AND CONFIRMED IT, THE THREAD OF THE SCREW WAS WORN. HE USED OTHER NEW SCREW AND FINISHED THE SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204478 REFLEX-HYBRID 4X14MM VARIABLE ANGLE SELF-DRIL.SCRW CERVICLE BONE SCREW KWP STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR