BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAKOMA-SL ACP SYSTEM

    MDR report key: 6245510 · Received January 12, 2017

    Report

    Report Number
    3008520015-2017-00002
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 12, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ALLIANCE PARTNERS, LLC (DBA ALLIANCE SPINE)
    Product Code
    KWQ
    PMA / PMN Number
    K141993
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, NAKOMA SCREW (PART 3100I-6004; LOT 21459S) WAS RECEIVED FROM CONTRACT MANUFACTURER, INSPECTED AND RELEASED INTO INVENTORY. ENGINEERING CONFIRMED VIA POST-OP X-RAY IMAGING THAT TWO NAKOMA FIXED SELF-TAPPING SCREWS AT C4 LOCATION HAD BACKED OUT OF PLATE. FUSION HAD OCCURRED. DEVICES ARE NOT AVAILABLE FOR EVALUATION; THEREFORE, NO FURTHER EVALUATION CAN BE DONE AT THIS TIME. BONE QUALITY OF THE PATIENT WAS OSTEOPOROTIC (CONTRAINDICATION IN IFU) AND COULD HAVE CONTRIBUTED TO THE SCREWS BACKING OUT. PATIENT KEPT THE DEVICE.

    Description of Event or Problem · 1

    DURING 9 MONTH POST-OPERATIVE FOLLOW-UP, X-RAY IMAGES REVEALED THAT TWO (2) NAKOMA-SL SCREWS IMPLANTED AT C4 LOCATION HAD BACKED OUT OF THE PLATE. THE NAKOMA-SL PLATE AND ALL FOUR (4) SCREWS WERE REMOVED BECAUSE OF THE SCREW BACK OUT. THE DEVICES WERE NOT REPLACED WITH ANOTHER ACP SYSTEM BECAUSE FUSION OF THE CERVICAL SPINE HAD OCCURRED. BONE QUALITY OF THE PATIENT WAS REPORTED AS OSTEOPOROTIC. NO INJURIES OR ISSUES WERE REPORTED. ALL THE HARDWARE WAS GIVEN TO THE PATIENT ONCE REMOVED. ORIGINAL ACDF SURGERY WAS PERFORMED ON (B)(6) 2016. THIS EVENT INVOLVED THREE DEVICES. THIS IS REPORT 2 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30416 NAKOMA-SL ACP SYSTEM ANTERIOR CERVICAL PLATING SYSTEM KWQ ALLIANCE PARTNERS, LLC (DBA ALLIANCE SPINE) 3100I-6004 21459S

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention