BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NILE ALTERNATIVE FIXATION SPINAL SYSTEM

    MDR report key: 6113646 · Received November 18, 2016

    Report

    Report Number
    3004774118-2016-00094
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 19, 2016
    Manufacturer
    K2M, INC.
    Product Code
    OWI
    PMA / PMN Number
    K143350
    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 REPORTED DIFFICULTY IN INSERTING THE SET SCREW WAS LIKELY CAUSED BY THE CLAMP BEING IMPLANTED AND EXPLANTED MULTIPLE TIMES. THE FRACTURED LAMINA OF THE PATIENT WAS LIKELY CAUSED BY THE MULTIPLE ATTEMPTS OF TENSIONING AND LOOSENING THE CLAMP ON THE LAMINA. 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 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 10/19/2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A NILE CLAMP WAS IMPLANTED AND EXPLANTED MULTIPLE TIMES DUE TO MOTOR SIGNAL LOSS. LAMINA FRACTURE WAS NOTICED AT THE LEVEL OF ISSUE. AFTER REPEATED REMOVALS AND REPLACEMENT THERE WAS DIFFICULTY INSERTING ONE OF THE SET SCREWS. SURGERY TOOK PLACE (B)(6) 2016.

    Description of Event or Problem · 1

    ON 10/19/2016 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH A NILE CLAMP WAS IMPLANTED AND EXPLANTED MULTIPLE TIMES DUE TO MOTOR SIGNAL LOSS. LAMINA FRACTURE WAS NOTICED AT THE LEVEL OF ISSUE. SURGERY TOOK PLACE (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763873 NILE ALTERNATIVE FIXATION SPINAL SYSTEM BONE FIXATION CERCLAGE OWI K2M, INC. EPAH

    Patients

    Seq Age Sex Outcome Treatment
    1