BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8069031 · Received November 14, 2018

    Report

    Report Number
    3005180920-2018-00897
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 17, 2018
    Report Date
    November 14, 2018
    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 · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2018. LOT 1820933: 200 ITEMS MANUFACTURED AND RELEASED ON 03 OCTOBER 2018. EXPIRATION DATE: 2023-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 70 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED: PEDICLE SCREW MUST PEDICLE SCREWDRIVER - MIS HYBRID REFERENCE (B)(4). LOT 1755117: 15 ITEMS MANUFACTURED AND RELEASED ON 29 MARCH 2018 . NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR REPORTED EVENT. VISUAL INSPECTION PERFORMED THE (B)(6) 2018 BY R&D PRODUCT MANAGER. PICTURES RECEIVED WITH THE COMPLAINT HAVE BEEN ALSO CONSIDERED. THE FIRST THREAD OF THE PEDICLE SCREW HEAD (TULIP) IS DAMAGED. THE IMPLANT CAN STILL ENGAGE A PEDICLE SCREWDRIVER WITH SOME FRICTION. PROCEDURES AND CONTROL METHODS HAVE BEEN ESTABLISHED TO ENSURE 100% VERIFICATION OF THE CORRECT ASSEMBLING AND COUPLING WITH THE RELATED INSTRUMENTS DURING FINAL INSPECTION BEFORE PACKAGING OF THE IMPLANTS. THEREFORE IT CAN BE EXCLUDED THAT THE IMPLANT WAS ALREADY DEFECTIVE WHEN THE BOX WAS OPENED. DEFORMATION/DAMAGE COULD HAVE OCCURRED DUE TO HANDLING E.G. BECAUSE OF CROSS THREADING WITH THE PEDICLE SCREWDRIVER.

    Description of Event or Problem · 1

    THE NURSE WAS NOT ABLE TO ENGAGE THE PEDICLE SCREW WITH THE SCREWDRIVER. AFTER MANY ATTEMPTS, DEBRIS WAS GENERATED ON THE PEDICLE SCREW THREAD. THE SURGERY WAS FINISHED WITH THE BACK UP IMPLANT. NO CRITICAL DELAY. THE SAME SCREWDRIVER WAS ABLE TO ENGAGE WITH THE BACK UP IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907960 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1820933 07630030857584

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other