BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENALI SPINAL SYSTEM

    MDR report key: 5749176 · Received June 24, 2016

    Report

    Report Number
    3004774118-2016-00039
    Event Type
    Injury
    Date Received
    June 24, 2016
    Date of Event
    December 21, 2015
    Report Date
    May 26, 2016
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    UDI-DI
    10888857003842
    PMA / PMN Number
    K042635
    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 PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS NO LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. IF MORE INFORMATION BECOMES AVAILABLE MANUFACTURER WILL FILE A FOLLOW-UP REPORT. DISPOSED OF BY HOSPITAL.

    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 NO LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE IMPLANTS WERE DISPOSED OF AT THE HOSPITAL NO PHYSICAL, MATERIAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. THE SCREW DENSITY WAS BELOW ONE SCREW PER LEVEL, WHICH MAY HAVE PLACED MORE STRESS ON THE SET SCREW AND CONTRIBUTED TO IT BACKING OUT. HOWEVER, NO ROOT CAUSE(S) COULD BE DETERMINED. A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. DISPOSED OF BY HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED TO K2M, INC. ON 05/26/2016 THAT A POST-OP SET SCREW BACK OUT OCCURRED AT THE DISTAL END OF THE CONSTRUCT. THE PATIENT WAS REVISED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A POST-OP SET SCREW BACK OUT OCCURRED AT THE DISTAL END OF THE CONSTRUCT. THE PATIENT WAS REVISED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402084 DENALI SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. UNKNOWN 10888857003842

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention M101-07545 LOT UNKNOWN