BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    MDR report key: 9171183 · Received October 9, 2019

    Report

    Report Number
    3005180920-2019-00848
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 3, 2019
    Report Date
    November 11, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630040716086
    PMA / PMN Number
    K171758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY MEDACTA R&D SPINE PRODUCT MANAGER: THE THREE SETSCREW 03.50.204 HAVE THE BEGINNING OF THE THREAD WITH A SMALL DEFORMATION. THE POTENTIAL ROOT CAUSE OF THIS DEFORMATION IS DUE TO THE CROSS THREADING WITH THE PEDICLE SCREW HEAD WHOSE RISK IS MORE HIGH IN THE FREE HAND TECHNIQUE. ADDITIONAL INFORMATION: IN ORDER TO REDUCE THE RISK OF CROSS THREADING, IT CAN BE USED THE REDUCTION DEVICE (ONE STEP REDUCER / TWO STEP REDUCER / LOCKING TOWER) OR THE ENHANCED SETSCREW DRIVER.

    Description of Event or Problem · 0

    DEVICES ANALYSED BY MEDACTA R&D.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2019. LOT 1921204: 150 ITEMS MANUFACTURED AND RELEASED ON 16-MAY-2019. EXPIRATION DATE: 2024-04-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 96 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT (SECOND CASEREPORTED IN THIS SAME COMPLAINT). ADDITIONAL DEVICE INVOLVED BATCH REVIEW PERFORMED ON (B)(6) 2019: PEDICLE SCREW 03.50.204 MUST COMBINED SETSCREW H4-T27 - (4X) (K171758) LOT 1920258: 120 ITEMS MANUFACTURED AND RELEASED ON 15-FEB-2019. EXPIRATION DATE: 2024-02-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 82 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE SURGEON WAS NOT ABLE TO INSERT THE 4 OUT OF 3 SET SCREWS INTO THE PEDICLE SCREW HEADS DUE TO THE CROSSS-THREADING, ALTHOUGH THE SURGEON PERFORMED THE SURGERY IN ACCORDANCE WITH THE SURGICAL TECHINIQUE. THE SURGEON REPLACED THE NEW SET SCREWS. DUE TO THIS EVENT THE SURGERY WAS PROLONGED ABOUT 30 MINUTES, TOTAL SURGERY TIME 210 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964630 PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X) SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1921204 07630040716086

    Patients

    Seq Age Sex Outcome Treatment
    1 Other