BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X90 PEDICLE SCREW SYSTEM

    MDR report key: 7843684 · Received September 4, 2018

    Report

    Report Number
    3005031160-2018-00026
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Report Date
    September 4, 2018
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MNI
    UDI-DI
    M697N600003291
    PMA / PMN Number
    K052847
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY RECEIVED A PACKAGE OF BROKEN PEDICLE SCREWS AND A BROKEN ROD IN THE MAIL. THERE WERE NO COMPLAINT DETAILS RECEIVED WITH THE PACKAGE. THE COMPANY MADE MULTIPLE ATTEMPTS TO RETRIEVE DETAILS REGARDING THE RETURNED HARDWARE, NECESSARY DETAILS TO COMPLETE A COMPLAINT INVESTIGATION WERE UNABLE TO BE OBTAINED. IT IS UNKNOWN IF THE DAMAGE OCCURRED DURING REMOVAL. THERE WERE NO KNOWN PATIENT COMPLICATIONS. ADDITIONAL RELATED PART NUMBERS AND LOT NUMBERS ARE LISTED BELOW. N60000329, LOT# 153822; N60000318, LOT# 183174; N60000319, LOT# 159594; N60000329; LOT# 180244; N60000328; LOT# 177075; N60000305, LOT# 3557-01. DHR REVIEWS WERE PERFORMED FOR EACH LOT NUMBER. THERE WERE NO MANUFACTURING ANOMALIES IDENTIFIED IN THE DHRS. THE DEVICES MET ALL REQUIRED SPECIFICATIONS PRIOR TO BEING RELEASED TO DISTRIBUTABLE INVENTORY.

    Description of Event or Problem · 1

    THE COMPANY RECEIVED A PACKAGE OF BROKEN PEDICLE SCREWS AND A BROKEN ROD IN THE MAIL. THERE WERE NO COMPLAINT DETAILS RECEIVED WITH THE PACKAGE. THE COMPANY MADE MULTIPLE ATTEMPTS TO RETRIEVE DETAILS REGARDING THE HARDWARE. THERE WERE NO KNOWN PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683725 X90 PEDICLE SCREW SYSTEM PEDICLE SCREW SYSTEM MNI X-SPINE SYSTEMS, INC. N60000329 153822 M697N600003291

    Patients

    Seq Age Sex Outcome Treatment
    1 Other