BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 4840434 · Received June 12, 2015

    Report

    Report Number
    3004774118-2015-00030
    Event Type
    Injury
    Date Received
    June 12, 2015
    Date of Event
    November 30, 2014
    Report Date
    May 14, 2015
    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

    THE IMPLANTS REMAIN IN THE PATIENT AND COULD NOT BE EVALUATED. PATIENT HAS FUSED AND IS DOING WELL, THEREFORE NO REVISION IS EXPECTED. X-RAYS WERE MADE AVAILABLE FOR REVIEW. PER THE MANUFACTURING AND INSPECTION RECORDS THE SCREWS WERE MANUFACTURED TO SPECIFICATION. FOLLOW-UP #1/FINAL REPORT ISSUED TO INCLUDE K2M'S RISK ASSESSMENT REVIEW AS INDICATED BELOW. "RISK: THE EVEREST RISK ANALYSIS, RISK-031 REV 1: HAZARD ANALYSIS, LINES 5-10: SCREW BREAKAGE, ADDRESSES THE SCENARIO DESCRIBED IN THIS COMPLAINT/MDR. THE PROBABILITY AND SEVERITY ASSOCIATED WITH THESE HAZARDS ARE FOUND TO BE ACCURATELY ASSIGNED. NO EDITS ARE REQUIRED. TECHNIQUE: THE SURGICAL TECHNIQUE GUIDE AND IFU ARE ACCURATE AND AVAILABLE TO THE SURGEON - NO EDITS REQUIRED. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. (B)(4). K2M INC., DOES NOT EXPECT TO RECEIVE ADDITIONAL INFORMATION IN REGARDS TO THIS CASE AND THEN, CONSIDERS THIS TO BE A CLOSE-OUT REPORT.

    Additional Manufacturer Narrative · 1

    A BILATERAL SCREW FRACTURE WAS REPORTED TO MANUFACTURER ON (B)(6) 2015. THE PATIENT WAS REVISED ON (B)(6) 2014. DEVICE WAS DISPOSED OF. X-RAYS WERE MADE AVAILABLE TO MANUFACTURER. MANUFACTURER WILL FILE A FOLLOW-UP REPORT WHEN NEW INFORMATION IS AVAILABLE. DEVICE WAS NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A BILATERAL SCREW FRACTURE WAS REPORTED TO MANUFACTURER ON (B)(6) 2015. PATIENT WAS NOT REVISED.

    Description of Event or Problem · 1

    A BILATERAL SCREW FRACTURE WAS REPORTED TO MANUFACTURER ON 5/14/2015. PATIENT WAS REVISED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385290 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. BKGX, AXPG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R