BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIXED SELF-DRILLING SCREW DIAM. 4X14MM (2X)

    MDR report key: 7166916 · Received January 5, 2018

    Report

    Report Number
    3005180920-2017-00818
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 8, 2017
    Report Date
    February 16, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630030840920
    PMA / PMN Number
    K140361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 JANUARY 2018: LOT 141367: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 OCTOBER 2014. EXPIRATION DATE: 2019-09-30. NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, (B)(4)ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION PERFORMED ON 15TH FEBRUARY 2018 BY R&D DEPARTMENT: DURING THE VISUAL INSPECTION IT WAS OBSERVED AND CONFIRMED THAT ONE OUT OF FOUR PRONGS WAS BROKEN AT THE BASE AS PER FRAGILE FRACTURE. THIS KIND OF FAILURE IS LIKELY DUE TO HIGH STRESS GENERATED AT THE IMPLANT-INSTRUMENT INTERFACE BECAUSE OF UNCORRECT ALIGNMENT AS WELL AS NOT PREPARATION OF THE SCREW PILOT HOLE. IN ORDER TO EASE THE POSITIONING OF SCREW, DEDICATED INSTRUMENT LIKE TAP WERE INTRODUCED ON THE MARKET TO PROPERLY PREPARE THE PILOT HOLE. ADDITIONALLY, IN ORDER TO AVOID THE RISK OF MISALIGNMENT AT THE SCREW-SCREWDRIVER INTERFACE , A NEWEST RIGID SCREWDRIVER WAS INTRODUCED ON THE MARKET AS FROM JULY 2016. THIS SCREWDRIVER IS AIMED TO RIGIDLY SECURE THE BONE-SCREW ON THE DRIVER TIP AND, THEREFORE, AVOID THE RISK OF MISALIGNMENT ANG TOGGLE AT THE IMPLANT-INSTRUMENT INTERFACE. HOWEVER, WE HAVE NOT EVIDENCE WHICH KIND OF TECHNIQUE WAS PERFORMED TO POSITION THE SCREW (PILOT HOLE PREPARATION AND/OR USAGE OF MODULAR RIGID SCREWDRIVER).

    Description of Event or Problem · 1

    DURING A C5-C7 ACDF ONE OF THE SCREWS BROKE UPON FINAL TIGHTENING. THE SURGEON WAS ABLE TO RECOVER THE FULL SCREW FROM THE PATIENT. THE SURGEON USED A SECONDARY SCREW TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10941 FIXED SELF-DRILLING SCREW DIAM. 4X14MM (2X) SCREW FOR CERVICAL PLATE KWQ MEDACTA INTERNATIONAL SA 141367 07630030840920

    Patients

    Seq Age Sex Outcome Treatment
    1 Other