BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 6586506 · Received May 23, 2017

    Report

    Report Number
    0009617544-2017-00217
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    April 25, 2017
    Report Date
    July 24, 2017
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    UDI-DI
    07613327000993
    PMA / PMN Number
    K113666
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG# 48230000, LOT# EKD. DATE OF EXPLANT: (B)(6) 2017. VISUAL INSPECTION, DEVICE HISTORY REVIEW, COMPLAINT HISTORY REVIEW, RISK ASSESSMENT. MANUFACTURING RECORDS WERE REVIEWED FOR THE CORRESPONDING LOT AND NO RELEVANT ISSUES WERE IDENTIFIED. THE VISUAL INSPECTION OF THE BLOCKERS CONFIRMED INDENTATIONS AT THE BASE OF BLOCKERS. THE MOST LIKELY ROOT CAUSE OF THE EVENT IS THE ACTIVITY LEVEL OF THE PATIENT ALONG WITH ROD NOT FULLY SEATED IN THE SCREW LEADING TO ROD SLIPPAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE 5/23/2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; DURING REVISION SURGERY- WAS NOTED BY SURGEON THAT THERE WAS ROD SLIPPAGE. UPDATE (B)(6) 2017. THE REASON FOR THE REVISION SURGERY WAS DUE TO PSEUDOARTHRITIS, NON FUSION. WHEN THE SURGEON WENT IN TO TREAT THE PSEUDOARTHRITIS, THE ROD SLIPPAGE WAS NOTICED. PRIOR TO THE REVISION SURGERY, THERE WAS NO INDICATION/ISSUE NOTICED INVOLVING ANY OF THE PREVIOUS IMPLANTED PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367797 XIA 3 TITANIUM BLOCKER PEDICLE SCREW SPINAL SYSTEM MNI STRYKER SPINE-FRANCE 482335030 EKD 07613327000993

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR