BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABO ACP SYSTEM

    MDR report key: 6973506 · Received October 24, 2017

    Report

    Report Number
    3008853203-2017-00007
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 28, 2017
    Report Date
    September 28, 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. NO LOT NUMBERS AVAILABLE. PARTS ARE NOT AVAILABLE FOR REVIEW. TREND ANALYSIS HAS BEEN REVIEWED AND INDICATES NO PATTERN FOR THE P/N. THIS IS THE SECOND INSTANCE FROM THE SAME CLINICIAN AS (B)(4). A REVIEW OF THE ASSOCIATED DEVICE HISTORY FILES FOR 81-1216 HAS NOT PROVIDED ANY SUBSTANTIAL INFORMATION CONTRIBUTING TO THE ROOT CAUSE ANALYSIS DETERMINATION. FINISHED PRODUCT MET SPECIFICATIONS. RAW MATERIAL MET SPECIFICATIONS. FAILURE MODE IS NOT RELATED TO THE MECHANICAL PROPERTIES OF THE DEVICE. THERE ARE MULTIPLE TECHNIQUES FOR THE DELIVERY OF AN ANTERIOR CERVICAL PLATE AS WITH ANY SURGICAL PROCEDURE. EACH SURGEON MUST CONSIDER THE PARTICULAR NEEDS OF EACH PATIENT AND MAKE THE APPROPRIATE ADJUSTMENTS WHEN NECESSARY AND AS REQUIRED. SURGEON SHOULD REFER TO THE SURGICAL TECHNIQUE AS NEEDED.

    Description of Event or Problem · 1

    POST-OP SCREW BREAKAGE IN PATIENT. C4-6 ACDF. SURGERY (B)(6) 2017. FOUND ON ROUTINE FOLLOW UP BY CLINICIAN. THE SAME CLINICIAN AS PER (B)(4). PATIENT ASYMPTOMATIC, PLAN WILL BE TO MONITOR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750315 CABO ACP SYSTEM 4.0MM VARIABLE SELF TAPPING SCREW 16MM KWQ NEUROSTRUCTURES, INC. 00841508101673

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR