BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABO ACP SYSTEM

    MDR report key: 6998232 · Received November 2, 2017

    Report

    Report Number
    3008853203-2017-00008
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 16, 2017
    Report Date
    October 16, 2017
    Manufacturer
    NEUROSTRUCTURES, INC.
    Product Code
    KWQ
    UDI-DI
    00841508101673
    PMA / PMN Number
    K142060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED IS NOT SUFFICIENT FOR ROOT CAUSE ANALYSIS OF THE REPORTED EVENT. LOT NUMBERS WERE NOT PROVIDED. THE DEVICES REMAIN IMPLANTED AND WERE NOT RETURNED FOR EXAMINATION. IMAGES WERE PROVIDED FOR 3-MONTH POST-OP AND AT 6-MONTH POST-OP. NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED. A REVIEW OF THE ASSOCIATED DEVICE HISTORY FILES FOR ALL LOTS OF 81-1214 AND 81-1216 HAS NOT PROVIDED ANY SUBSTANTIAL INFORMATION CONTRIBUTING TO THE ROOT CAUSE ANALYSIS DETERMINATION. WHILE BOTH 81-1214 AND 81-1216 ARE LISTED, IT APPEARS THAT THE DEVICES UNDER REVIEW WERE 81-1216. FINISHED PRODUCT MET DIMENSIONAL SPECIFICATIONS. RAW MATERIAL CERTIFICATIONS WERE REVIEWED AGAINST SPECIFICATIONS AND FOUND TO BE WITHIN RANGE. FAILURE MODE DOES NOT APPEAR RELATED TO THE MECHANICAL PROPERTIES OF THE DEVICE. 3-MONTH POST-OP X-RAY IDENTIFIED NO OBSERVABLE ISSUES WITH USE OF THE DEVICES OR IMPLANTATION. FRACTURE WAS OBSERVED IN X-RAY AT 6-MONTH FOLLOW-UP POST OP. THIS IS THE THIRD OF THREE REPORTED INSTANCES OF SCREW FRACTURE FROM THE SURGEON. SURGEON HAS PERFORMED 44 COMPARABLE SURGERIES SINCE JANUARY 2016. NO HISTORICAL INFORMATION WAS OBTAINED ON PRIOR FRACTURES OR CHANGES TO CAGE/PLATE/SCREW CONSTRUCT. UNABLE TO CONDUCT ANY ANALYSIS OF THE FRACTURE. THE VARIABLE ANGLE SCREWS ARE DESIGNED FOR UP TO 8° ANGULATION FROM NEUTRAL. THE SCREW WILL NO LONGER PROVIDE ANGULATION BEYOND THE 8° AND WILL PERFORM AS A FIXED SCREW WHEN SUBJECTED TO LOADS. WE WERE UNABLE TO ASCERTAIN THE ANGULATION OF THE SCREWS AS THE IMAGES PROVIDED WERE NOT IDENTICAL IN THEIR REFERENCE PLANE.

    Description of Event or Problem · 1

    POST-OP LEFT SIDE CAUDAL SCREW FRACTURE. POST-OP RIGHT SIDE SCREW BACK OUT. SURGERY ON (B)(6) 2017. FOUND ON ROUTINE FOLLOW UP BY CLINICIAN. THE SAME CLINICIAN AS PER (B)(4) AND (B)(4). PATIENT ASYMPTOMATIC, PLAN WILL BE TO MONITOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776721 CABO ACP SYSTEM 4.0MM VARIABLE SELF TAPPING SCREW 16MM KWQ NEUROSTRUCTURES, INC. 00841508101673

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR