BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM

    MDR report key: 9086487 · Received September 19, 2019

    Report

    Report Number
    3005180920-2019-00773
    Event Type
    Injury
    Date Received
    September 19, 2019
    Date of Event
    August 20, 2019
    Report Date
    October 23, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857577
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D SPINE PROJECT MANAGER: THE TWO PEDICLE SCREWS INSERTED IN L4 LOOSENED AND WERE SUBSTITUTED WITH A REVISION SURGERY. THE TWO REMOVED SCREWS DO NOT PRESENT ANY SCRATCHES AND THEIR FUNCTIONALITY HAVE BEEN SUCCESSFULLY VERIFIED IN TERMS OF COUPLING WITH THE SCREWDRIVER (BOTH TORX AND THREADED CONNECTION), K-WIRE AND REDUCTION TOWERS (E.G. WITH THE 1-STEP REDUCER). FOR THESE REASONS, THE ROOT CAUSE THAT LED TO THE PERFORMED REVISION SURGERY, CANNOT BE ADDRESSED TO ANY MECHANICAL OR FUNCTIONAL IMPLANT DEFECTS.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 26 AUGUST 2019. LOT 1920237: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2019. EXPIRATION DATE: 2024-03-09. 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. ADDITIONAL IMPLANT INVOLVED PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM (K141988) LOT. 1822132. BATCH REVIEW PERFORMED ON 26 AUGUST 2019. LOT 1822132: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JAN-2019. EXPIRATION DATE: 2024-01-08. 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.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY PERFORMED AT L4-L5-S1 ON AUGUST 1. REVISION SURGERY PERFORMED ON AUGUST 20 DUE TO THE PEDICLE SCREW LOOSENING AT BOTH OF L4. THE REASON OF THE LOOSENING WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    884905 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1920237 07630030857577

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention