BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAKOMA-SL ACP SYSTEM

    MDR report key: 6246778 · Received January 12, 2017

    Report

    Report Number
    3008520015-2016-00003
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    September 9, 2016
    Report Date
    October 7, 2016
    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

    THE NAKOMA-SL 4.0MM X 14MM SELF-TAPPING SCREWS (PART #3100I-6004, LOT #24347S), WERE RECEIVED FROM THE CONTRACTED MANUFACTURER AS PART OF A LOT QUANTITY OF 305 ON 3/14/2016. THE LOT WAS INSPECTED AND RELEASED TO INVENTORY. AN ENGINEERING EVALUATION WAS COMPLETED ON THE DEVICES INVOLVED IN THE REPORTED EVENT. EVALUATION INCLUDED VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED FOUR (4) SELF-TAPPING SCREWS (PART #3100I-6004; LOT #24347S), 22MM 1-LEVEL PLATE (31001-1005; LOT #21672S), AND FIXED SINGLE BARREL DRILL GUIDE (PART #3100T-1400; LOT # SM60277), AND THEN SIMULATED USE TESTING IN AN ATTEMPT TO RECREATE THE REPORTED EVENT USING THE RETURNED DEVICES BY IMPLANTING EACH OF THE FOUR (4) SCREWS INTO EACH OF THE PLATE'S FOUR (4) SCREW HOLES PER THE SURGICAL TECHNIQUE USING THE RETURNED DRILL GUIDE, A DRILL BIT THAT WAS THE SAME CONFIGURATION AS THE INSTRUMENT REFERENCED IN THE REPORTED EVENT, AND A SAW BONE. RESULTS WERE AS FOLLOWS: 1) DEVICES WERE WITHIN SPECIFICATION; AND 2) ZERO FAILURES WERE OBSERVED DURING THE SIMULATED USE EVALUATION; ALL FOUR (4) SCREWS WERE SUCCESSFULLY IMPLANTED IN EACH OF THE FOUR (4) PLATE HOLES WITHOUT PASSING THRU THE PLATE. OBSERVED THE MATING CONNECTION BETWEEN THE DRILL GUIDE AND PLATE HOLE WAS SLIGHTLY UNSTABLE. BASED ON THE EVALUATION PERFORMED, THE FAILURE MODE COULD NOT BE RE-CREATED (NOT CONFIRMED). PARTS INVOLVED IN THE REPORTED EVENT WERE FOUND TO BE WITHIN SPECIFICATION WITH NO IRREGULARITIES IDENTIFIED AND TESTING COULD NOT SUBSTANTIATE THE SCREW PASSING THRU THE PLATE FAILURE MODE ALLEGED IN THE COMPLAINT. IT WAS OBSERVED, HOWEVER, THAT THE MATING CONNECTION BETWEEN THE DRILL GUIDE AND PLATE HOLE WAS SLIGHTLY UNSTABLE, WHICH COULD AFFECT PROPER SCREW HOLE PREPARATION. UNSTABLE CONNECTION AT THIS INTERFACE COULD CAUSE THE DRILLED HOLE TO BE OFF AXIS, RESULTING IN A DRILLED HOLE OUTSIDE THE NAKOMA-SL SYSTEM'S ALLOWABLE 7-DEGREE ANGULATION.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE DOCTOR WAS PERFORMING A C5-C7 ACDF PROCEDURE. DURING IMPLANTATION OF A NAKOMA-SL 22MM 1-LEVEL PLATE (PART 3100I-1005, LOT #21672S) AND FOUR (4) NAKOMA-SL 4.0MM X 14MM SELF-TAPPING SCREWS (PART #3100I-6004, LOT #24347S), THE SCREWS PASSED THROUGH THE PLATE. A FIXED SINGLE BARREL DRILL GUIDE (PART #3100T-1400, LOT #SM60277) AND A 2.3MM X 12MM DRILL BIT WAS BEING USED TO PREPARE THE HOLES DURING THE SURGERY. ALL FOUR (4) SCREWS AND PLATE WERE SAFELY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER SYSTEM. NO PATIENT INJURIES WERE REPORTED. THE NAKOMA-SL 1-LEVEL PLATE (31001-1005; LOT #21672S), AND THE FOUR (4) SELF-TAPPING SCREWS (PART #3100I-6004; LOT #24347S) WERE RETURNED FOR PRODUCT EVALUATION. IN ADDITION, THE FIXED SINGLE BARREL DRILL GUIDE THAT WAS USED DURING THE PROCEDURE (PART # 3100T-1400; LOT # SM60277) WAS ALSO RETURNED. THIS EVENT INVOLVED TWO DEVICES. THIS IS REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30392 NAKOMA-SL ACP SYSTEM ANTERIOR CERVICAL PLATING SYSTEM KWQ ALLIANCE PARTNERS LLC (DBA ALLIANCE SPINE) 3100I-6004 24347S

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR