BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 45MM

    MDR report key: 4724188 · Received April 23, 2015

    Report

    Report Number
    0009617544-2015-00181
    Event Type
    Injury
    Date Received
    April 23, 2015
    Date of Event
    March 26, 2015
    Report Date
    March 27, 2015
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CAT: 482365545, LOT: 117809. METHOD: DEVICE NOT RETURNED. DEVICE HISTORY REVIEW. RESULTS: MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. THE DEVICE WAS NOT RECEIVED BACK, AS IT WAS DISCARDED BY THE CUSTOMER, SO TESTING AND INSPECTION COULD NOT BE PERFORMED TO AID IN ROOT CAUSE ANALYSIS. CONCLUSION: BECAUSE THE DEVICE IS UNAVAILABLE FOR EVALUATION, THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, SURGERY WAS PERFORMED FOR IDIOPATHIC SCOLIOSIS. T10-L3 WERE FIXED WITH SCREWS. AFTER THAT, L3 SCREW BREAKAGE WAS FOUND AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, SURGERY WAS PERFORMED FOR IDIOPATHIC SCOLIOSIS. T10-L3 WERE FIXED WITH SCREWS. AFTER THAT, L3 SCREW BREAKAGE WAS FOUND AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270705 XIA DEFORMITY UNIPLANAR SCREW REDUCTION DIA 5.5 X 45MM PEDICLE SCREW SPINAL SYSTEM MNI STRYKER SPINE-FRANCE 117809

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention