BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP POLYAXIAL SCREW 5.5 X 45MM

    MDR report key: 5934188 · Received September 7, 2016

    Report

    Report Number
    3005525032-2016-00108
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    May 30, 2016
    Report Date
    August 12, 2016
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    KWP
    UDI-DI
    04546540148919
    PMA / PMN Number
    K060361
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG# 03821545. LOT# B25470. PMA/510(K)# K060361. THE DEVICE IS STILL IMPLANTED SO IT WAS NOT RETURNED. DESIGN HISTORY REVIEW WAS PERFORMED. NO MANUFACTURING ISSUES IDENTIFIED. THE IFU STATES THAT IMPLANTED DEVICES MAY FATIGUE AS THEY ARE NOT MEANT TO INDEFINITELY WITHSTAND THE NORMAL LOADS OF BONE AND ARE ONLY MEANT TO AID IN SUPPORT DURING FUSION OF THE VERTEBRAE. IF THE PATIENT IS INVOLVED IN AN OCCUPATION OR ACTIVITY WHICH APPLIES INORDINATE STRESS UPON THE IMPLANT (E.G., SUBSTANTIAL WALKING, RUNNING, LIFTING, OR MUSCLE STRAIN) THE SURGEON MUST ADVICE THE PATIENT THAT RESULTANT FORCES CAN CAUSE FAILURE OF THE DEVICE." WITHOUT THE DEVICE AND FURTHER INFORMATION REGARDING THE PATIENT, THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY AND IS MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585546 XIA LP POLYAXIAL SCREW 5.5 X 45MM SPINAL INTERLAMINAL FIXATION ORTHOSIS KWP STRYKER SPINE-SWITZERLAND B25470 04546540148919

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other