BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI SPINAL SYSTEM

    MDR report key: 6910708 · Received October 3, 2017

    Report

    Report Number
    3004774118-2017-00136
    Event Type
    Injury
    Date Received
    October 3, 2017
    Date of Event
    September 11, 2017
    Report Date
    September 5, 2017
    Manufacturer
    K2M, INC.,
    Product Code
    NKB
    PMA / PMN Number
    K133944
    Adverse Event
    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 WAS NOT 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. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE ROD WAS NOT RETURNED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. FURTHER INVESTIGATION DETERMINED THAT THE ROD DID NOT CONTRIBUTE TO THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WAS NOT 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 THE PATIENT HAD EXPERIENCED LEG PAIN AND SCANS SHOWED ROD MOVEMENT. PATIENT WAS REVISED (B)(6) 2017. (RELATED TO 3004774118-2017-00148 AND 3004774118-2017-00149).

    Description of Event or Problem · 1

    ON 09/05/2017 IT WAS REPORTED TO K2M, INC. THAT THE PATIENT HAD EXPERIENCED LEG PAIN AND SCANS SHOWED ROD MOVEMENT. PATIENT WAS REVISED 09.11.2017. (RELATED TO 3004774118-2017-00148 AND 3004774118-2017-00161).

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT THE PATIENT HAD EXPERIENCED LEG PAIN AND SCANS SHOWED ROD MOVEMENT. PATIENT WAS REVISED (B)(6) 2017. (RELATED TO 3004774118-2017-00148 AND 3004774118-2017-00161).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691703 DENALI SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEMS NKB K2M, INC., UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention 6101-2102808TL7-G2LOT: UNKNOWN| E5112-06545LOT: UNKNOWN