BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM

    MDR report key: 9374815 · Received November 26, 2019

    Report

    Report Number
    3005180920-2019-00988
    Event Type
    Injury
    Date Received
    November 26, 2019
    Date of Event
    October 25, 2019
    Report Date
    December 17, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857584
    PMA / PMN Number
    K141988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE PEDICLE SCREW, REF 03.52.323, LOT 1921243, IS ACCORDING TO THE SPECIFICATION. THE POTENTIAL ROOT CAUSE OF THE EVENT IS THE POOR QUALITY OF THE BONE OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 07 NOVEMBER 2019. LOT 1921243: 200 ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2019. EXPIRATION DATE: 2024-06-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 83 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED IN THE EVENT: PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1922914 (K141988). BATCH REVIEW PERFORMED ON 07 NOVEMBER 2019. LOT 1922914: 200 ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2019. EXPIRATION DATE: 2024-08-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 3 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM WAS INSERTED, BUT THE SCREW LOOSENING WAS CONFIRMED AFTER INSERTING THE SCREW COMPLETELY INTO THE BONE. ONE POSSIBLE REASON WAS THE PEDICLE SCREW THREAD WAS NOT FULLY DESIGNED NEAR THE PEDICLE SCREW TULIP, SO THE THREAD COULD NOT BE FIXED AT THE CORTICAL BONE COMPLETELY AND IT WAS NOT ABLE TO OBTAIN THE FIXING FORCE. PEDICLE SCREW WAS REPLACED WITH THE BACKUP PEDICLE SCREW. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 20 MINUTES. PATIENT BONE QUALITY WAS NOT GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173525 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM ENH. POLY-AXIAL PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1921243 07630030857584

    Patients

    Seq Age Sex Outcome Treatment
    1 Other