BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 5756172 · Received June 28, 2016

    Report

    Report Number
    3004774118-2016-00044
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 31, 2016
    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. A REVIEW OF ALL APPLICABLE MATERIAL, INSPECTION, MANUFACTURING, STORAGE AND DISTRIBUTION RECORDS ACCORDING TO THE DESCRIPTION OF THE PRODUCT USED WAS CONDUCTED. ALL RECORDS REVEALED THAT THE PRODUCT LOT WAS MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. THERE WERE HORIZONTAL ABRASIONS ON THE INNER COLLET THAT INDICATE THE SCREW WAS LIKELY FULLY LOCKED. THERE WAS A SIGNIFICANT ABRASION OBSERVED ON THE ROD CONSISTENT WITH ROD SLIP. NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT 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.

    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

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A ROD SLIPPED AT THE LEFT DISTAL SCREW APPROXIMATELY 3 YEARS POST-OP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO K2M, INC. ON (B)(6) 2016 THAT A ROD SLIPPED AT THE LEFT DISTAL SCREW APPROXIMATELY 3 YEARS POST-OP.

    Description of Event or Problem · 1

    IT WAS REPORTED TO K2M, INC. ON 05/31/2016 THAT A ROD SLIPPED AT THE LEFT DISTAL SCREW APPROXIMATELY 3 YEARS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409196 MESA SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. LFK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention 801-36545M LOT DGJW