BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 4785856 · Received May 20, 2015

    Report

    Report Number
    3004774118-2015-00022
    Event Type
    Malfunction
    Date Received
    May 20, 2015
    Date of Event
    April 21, 2015
    Report Date
    April 21, 2015
    Manufacturer
    K2M, INC.
    Product Code
    MNI
    PMA / PMN Number
    K141873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER WAS MADE AWARE THAT DURING A PATIENT'S SCHEDULED REVISION, THE SURGEON NOTICED THAT THE CONNECTOR SET SCREWS WERE LOOSE. SET SCREWS WERE RETURNED TO MANUFACTURER AND INVESTIGATION IS STILL IN PROGRESS. MANUFACTURER WILL FILE A FOLLOWUP REPORT ONCE NEW INFORMATION ABOUT THIS INVESTIGATION / EVENT IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    FINAL REPORT ISSUED TO INCLUDE K2M'S RISK ASSESSMENT REVIEW AS INDICATED BELOW. K2M INC DOES NOT EXPECT TO RECEIVE ADDITIONAL INFORMATION IN REGARDS TO THIS CASE AND THEN, CONSIDERS THIS TO BE A CLOSE-OUT REPORT. THERE IS NOT A FIRM CONCLUSION REGARDING THIS EVENT SINCE THE SUBJECT PART(S) WERE NOT RETURNED FOR EVALUATION. THE CONNECTORS WERE NOT RETURNED AND COULD NOT BE EVALUATED. EIGHT CONNECTOR SET SCREWS WERE RETURNED TO K2M. THEY ALL EXHIBITED DAMAGE ON THE ROD CONTACT SURFACE THAT IS CONSISTENT WITH DYNAMIC CONTACT WITH THE RODS. THE REPORTED LACK OF FUSION LIKELY CONTRIBUTED TO SET SCREWS BACKING OUT. FURTHERMORE, THE SET SCREWS OF THE IMPLANTS ARE NOT DESIGNED TO BE REMOVED. ATTEMPTING TO REMOVE THE SET SCREWS CAN DAMAGE THE THREADS OF THE CONNECTOR AND IS CONSISTENT WITH MISUSE. THIS COULD HAVE CONTRIBUTED TO THE INCIDENT. ROD CONNECTOR/ATR SET SCREW: RISK-000 REV 7, HAZARD ANALYSIS LINES: 109-124: ROD CONNECTOR IS DAMAGED AND/OR BREAKS ADDRESS THE POTENTIAL HAZARDS WHEN USED PER THE INDICATIONS STATED ON THE PRODUCT INSERT. THIS CASE WAS A GROWING ROD CONSTRUCT, WHICH IS CONSIDERED OFF-LABEL USE AND THEREFORE, NOT COVERED IN RISK-000. THE PROBABILITY AND SEVERITY ARE FOUND TO BE ACCURATELY ASSIGNED. NO EDITS ARE REQUIRED. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. THE SURGICAL TECHNIQUE GUIDE AND IFU ARE ACCURATE AND AVAILABLE TO THE SURGEON - NO EDITS REQUIRED. (B)(4).

    Description of Event or Problem · 1

    MANUFACTURER WAS MADE AWARE THAT DURING A PATIENT'S SCHEDULED REVISION, THE SURGEON NOTICED THAT THE CONNECTOR SET SCREWS WERE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328909 MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI K2M, INC. BNFK, BNFG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention