BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    K2M NAVIGATION INSTRUMENTS

    MDR report key: 7039507 · Received November 16, 2017

    Report

    Report Number
    3004774118-2017-00196
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 31, 2017
    Manufacturer
    K2M, INC.
    Product Code
    OLO
    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. NO CORRELATION COULD BE DETERMINED BETWEEN THE INSERTER AND THE RIGHT T4 PEDICLE SCREW BREACHING THE LATERAL WALL OF THE PEDICLE. IT IS POSSIBLE THAT THE SCREW DID NOT FOLLOW THE SAME TRAJECTORY OF THE PROBE THAT WAS USED TO PREPARE THE PEDICLE. FURTHER INVESTIGATION REVEALED THAT THE SURGICAL DELAY WAS DUE TO ADJUSTMENT OF THE O ARM TO GET RIGHT IMAGE AND BECAUSE OF THE BLOOD CLOT THAT INTERFERED WITH THE NAVIGATION SYSTEM AND ALSO REPOSITIONING OF REFERENCE FRAME FROM O ARM WHICH WAS BLOCKING THE SCREW DRIVER.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A PEDICLE SCREW BREACHED THE LATERAL WALL OF THE PEDICLE. AS A RESULT, THE SURGEON EXTENDED THE CONSTRUCT WHICH RESULTED IN A DELAY IN THE SURGERY. SURGERY TOOK PLACE (B)(6) 2017.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A PEDICLE SCREW BREACHED THE LATERAL WALL OF THE PEDICLE. AS A RESULT, THE SURGEON EXTENDED THE CONSTRUCT WHICH RESULTED IN A SIGNIFICANT DELAY IN THE SURGERY. SURGERY TOOK PLACE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815752 K2M NAVIGATION INSTRUMENTS NAVIGATION INSTRUMENT OLO K2M, INC. DUDRNB

    Patients

    Seq Age Sex Outcome Treatment
    1