BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET SCREW (TI-6AL-4V ELI)

    MDR report key: 5961029 · Received September 19, 2016

    Report

    Report Number
    2027467-2016-00070
    Event Type
    Injury
    Date Received
    September 19, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 16, 2016
    Manufacturer
    ALPHATEC SPINE INC
    Product Code
    NKB
    UDI-DI
    00840967124582
    PMA / PMN Number
    K133221
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE RETURNED SET SCREWS REVEALED MINOR THREAD PROFILE IRREGULARITIES. TO HELP AID IN DETERMINING ROOT CAUSE, THE SURGEON VISITED ALPHATEC ON (B)(6) 2016. HE INDICATED THAT ALTHOUGH CROSS-THREADING OCCURS DURING HIS CASES PERIODICALLY, THIS PARTICULAR CASE WAS CONCERNING BECAUSE IT APPEARED TO HAPPEN REPEATEDLY. THE SURGEON TOOK PART IN A BLIND EVALUATION IN WHICH SET SCREWS WERE INSERTED AT VARIOUS CROSS-THREADED ANGLES TO SEE IF A DIFFERENCE IN FEEL/PERFORMANCE COULD BE DETERMINED. DURING THIS EVALUATION, IT WAS NOTICED THAT THE SURGEON USES A NON-STANDARD SET SCREW INSERTION TECHNIQUE, WHICH WHEN COMBINED WITH THE DESIGN OF THE ARSENAL SET SCREWS WITH A LARGE LEAD-IN CHAMFER AND A MINIMIZED PROFILE, MAY INCREASE THE CHANCE OF CROSS-THREADING.

    Additional Manufacturer Narrative · 1

    THERE WERE A TOTAL OF SIX (6) ARSENAL SET SCREWS RETURNED FOR EVALUATION. ALL SIX (6) ARE THE SAME PRODUCT PART NUMBER/DESCRIPTION BUT CONTAIN FOUR (4) UNIQUE IDENTIFYING LOT NUMBERS. LOT 700941 (2 PIECES) MANUFACTURED 12/8/2015. LOT 7766301 (2 PIECES) MANUFACTURED 5/6/2016. LOT 696254 (1 PIECE) MANUFACTURED 9/14/2015. LOT 700611 (1 PIECE) MANUFACTURED 12/8/2015. THE ARSENAL SET SCREWS ARE CURRENTLY BEING EVALUATED. A FOLLOW UP REPORT WITH RESULTS OF THE INVESTIGATION WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    SURGEON HAD AN ISSUE WITH INTRA-OPERATIVE CROSS-THREADING/INITIATION OF SET SCREWS. THE EVENT CAUSED OVER A 30 MINUTE DELAY IN THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612274 SET SCREW (TI-6AL-4V ELI) PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE INC 47127 00840967124582

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other