BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENALI SPINAL SYSTEM

    MDR report key: 7291682 · Received February 23, 2018

    Report

    Report Number
    3004774118-2018-00007
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    January 23, 2018
    Report Date
    January 29, 2018
    Manufacturer
    K2M INC.
    Product Code
    LXH
    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. 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.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS RETURNED FOR EVALUATION BUT EVALUATION IS STILL IN PROGRESS. UPON COMPLETION OF EVALUATION OF THE SUBJECT PART, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    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 DISTAL TIP WAS CONFIRMED TO BE BROKEN AT THE HEXALOBE. THE FRACTURE FACE WAS CONSISTENT WITH FAILURE IN TORSIONAL OVERLOAD WHICH COULD HAVE RESULTED IN THE FAILURE.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP SHEARED OFF AND FUSED INTO THE SCREW. THE TORQUE WRENCH TIP REMAINS IN THE PATIENT CONFINED TO THE SCREW. SURGERY TOOK PLACE (B)(6) 2018.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP SHEARED OFF AND FUSED INTO THE SCREW. THE TORQUE WRENCH TIP REMAINS IN THE PATIENT CONFINED TO THE SCREW. SURGERY TOOK PLACE (B)(6) 2018.

    Description of Event or Problem · 1

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A TORQUE WRENCH TIP SHEARED OFF AND FUSED INTO THE SCREW. THE TORQUE WRENCH TIP REMAINS IN THE PATIENT CONFINED TO THE SCREW. SURGERY TOOK PLACE (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135845 DENALI SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM LXH K2M INC. EDPU011

    Patients

    Seq Age Sex Outcome Treatment
    1