BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI MI SPINAL SYSTEM

    MDR report key: 6168978 · Received December 13, 2016

    Report

    Report Number
    3004774118-2016-00103
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 17, 2016
    Manufacturer
    K2M, INC.
    Product Code
    HXC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. A REVIEW OF ALL APPLICABLE MATERIAL, INSPECTION, MANUFACTURING, AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCT(S) USED WAS CONDUCTED. ALL RECORDS REVEALED THAT ALL PRODUCT(S) LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. THE INSTRUMENT WAS DETERMINED TO BE WITHIN CALIBRATION. IT WAS LIKELY THAT THE TIP SHEARED DUE TO OVER-TORQUING OUR INVESTIGATION OF THE PRODUCT AND REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO MANUFACTURING DISCREPANCIES OR MATERIAL DEFECTS, NOR DID IT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS. NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP BROKE OFF IN A SET SCREW AND WAS UNABLE TO BE REMOVED. THE TIP REMAINS EMBEDDED WITHIN THE SET SCREW INSIDE OF THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP BROKE OFF IN A SET SCREW AND WAS UNABLE TO BE REMOVED. THE TIP REMAINS EMBEDDED WITHIN THE SET SCREW INSIDE OF THE PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP BROKE OFF IN A SET SCREW AND WAS UNABLE TO BE REMOVED. THE TIP REMAINS EMBEDDED WITHIN THE SET SCREW INSIDE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822110 DENALI MI SPINAL SYSTEM WRENCH HXC K2M, INC. CMDP011

    Patients

    Seq Age Sex Outcome Treatment
    1