BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM

    MDR report key: 12961659 · Received December 8, 2021

    Report

    Report Number
    1526439-2021-02516
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 10, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034199528
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE HISTORY LOT A REVIEW OF THE RECEIVING INSPECTION (RI) FOR FEN OPEN LONG CANNULA INT WAS CONDUCTED IDENTIFYING THAT LOT NUMBER LC37008 WAS RELEASED IN A SINGLE BATCH. BATCH 1: LOT QTY OF UNITS WERE RELEASED ON 01 JUN 2021 WITH NO DISCREPANCIES. AS A RESULT, THE RI IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING A LOMBAR ARTHRODESIS PROCEDURE. THE EXPEDIUM CORTICAL FIX SCREWS WERE INSERTED. EACH ALIGNMENT GUIDE WAS FULLY THREADED INTO THE HEAD OF THE SCREW BUT THE EXPEDIUM CANULA WAS NOT CONNECTING. THE SURGEON DID NOT APPLY ANY EXCESSIVE PRESSURE ON THE CANULA, AND THE DISTAL PART OF THE CANULA BENT OR BROKE ANYWAY. FIVE (5) CANNULAS WERE USED: THREE (3) BENT AT THE DISTAL PART, AND TWO (2) BROKE. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM. THIS IS REPORT 4 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1860734 EXPEDIUM SPINE SYSTEM FENESTRATED SCREW OPEN CANNULA 16G X 160MM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB MEDOS INTERNATIONAL SàRL CH 279726500 LC37008 10705034199528

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown FEN OPEN CANNULA STRL| FEN OPEN CANNULA STRL| FEN OPEN CANNULA STRL| FEN OPEN CANNULA STRL| FEN OPEN CANNULA STRL| FEN OPEN CANNULA STRL| UNKNOWN ALIGNMENT GUIDE| UNKNOWN INSERTION INSTRUMENTS