BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM

    MDR report key: 8959079 · Received September 4, 2019

    Report

    Report Number
    3005180920-2019-00728
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Date of Event
    August 5, 2019
    Report Date
    September 4, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630040705837
    PMA / PMN Number
    K171170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 8 AUGUST 2019: LOT 1821264: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2018. EXPIRATION DATE: 2023-07-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: THE CROSS CONNECTOR, REF. 03.56.402, LOT. 1821264, ANALYZED IS ACCORDING TO THE SPECIFICATION AND THE FUNCTIONALITY IS GUARANTEED. THE DIFFICULTIES IN THE IMPLANT ASSEMBLING IS PROBABLY THE IMPINGEMENT WITH THE BONE STRUCTURE.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO SET THE STRAIGHT CROSS CONNECTOR TO THE ROD, BECAUSE THE CONNECTION PART WITH ROD WAS NARROW, THICK AND THE STRAIGHT CROSS CONNECTOR WAS IN CONTACT WITH THE BONE AROUND THE ROD. THE SURGEON FINISHED THE SURGERY WITHOUT USING THE STRAIGHT CROSS CONNECTOR. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752866 PEDICLE SCREW MUST STRAIGHT CROSS CONNECTOR 20MM SPINE IMPLANT CROSS CONNECTOR KWP MEDACTA INTERNATIONAL SA 1821264 07630040705837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other