BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAKOMA-SL ACP SYSTEM

    MDR report key: 4768621 · Received May 11, 2015

    Report

    Report Number
    3008520015-2015-00004
    Event Type
    Malfunction
    Date Received
    May 11, 2015
    Date of Event
    April 13, 2015
    Report Date
    May 6, 2015
    Manufacturer
    ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE)
    Product Code
    KWQ
    PMA / PMN Number
    K141993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE NAKOMA-SL VARIABLE SELF-TAPPING 4X14MM SCREWS (PART #3100I-8004; LOT #21538S) WERE INSPECTED WITH NO NON-CONFORMANCES AND RELEASED TO INVENTORY. CONFIRMED VIA POST-OPERATIVE X-RAY IMAGING THAT ONE (1) IMPLANTED NAKOMA-SL VARIABLE SELF-TAPPING 4X14MM SCREW (PART #3100I-8004; LOT #21538S) HAS BACKED OUT OF THE PLATE. THE DEVICE IS NOT AVAILABLE OR EVALUATION BECAUSE THE DR HAS DECIDED TO CONTINUE TO OBSERVE THE PATIENT; THEREFORE, NO FURTHER INVESTIGATION/EVALUATION CAN BE DONE AT THIS TIME. SHOULD THE DOCTOR DECIDE TO TAKE FURTHER ACTION, THE DEVICE BECOMES AVAILABLE, AND/OR ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED CONTAINING THE ADDITIONAL RELEVANT INFORMATION, INCLUDING RESULTS OF ANY PHYSICAL EVALUATION THAT WAS CONDUCTED (IF ANY).

    Description of Event or Problem · 1

    ON (B)(6) 2014, DR IMPLANTED A TWO (2) LEVEL NAKOMA-SL PLATE AND SCREWS. THE IMPLANTS WERE AS FOLLOWS: NAKOMA-SL 2-LEVEL 32MM PLATE (PART #3100I-2003-01; LOT #21677S) AND (6) NAKOMA-SL VARIABLE SELF-TAPPING 4X14MM SCREWS (PART #300I-8004; LOT #21538S). NO ISSUES OR INJURIES WERE REPORTED AT THE TIME OF SURGERY. ON (B)(6) 2015, DR REPORTED TO AN ALLIANCE SPINE FIELD REPRESENTATIVE THAT DURING A STANDARD FOUR (4) MONTH POST-OPERATIVE FOLLOW-UP ON (B)(6) 2015, TWO (2) X-RAY IMAGES REVEALED THAT ONE (1_ SCREW IMPLANTED AT C6 HAD BACKED UP AND OUT OF THE PLATE. PATIENT HAD NOT BEEN EXPERIENCING ANY PAIN OR COMPLAINING ABOUT UNUSUAL SYMPTOMS. DR HAS DECIDED TO CONTINUE TO OBSERVE THE PATIENT. DEVICE REMAINS IMPLANTED IN THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308359 NAKOMA-SL ACP SYSTEM ANTERIOR CERVICAL PLATING SYSTEM KWQ ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE) 3100I-8004 21538S

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR