BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST SPINAL SYSTEM

    MDR report key: 7167455 · Received January 5, 2018

    Report

    Report Number
    3004774118-2017-00210
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 5, 2017
    Report Date
    December 7, 2017
    Manufacturer
    K2M INC.
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    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 CRACKED DISTAL TIP IS CONSISTENT WITH OVER-TORQUEING, MOST LIKELY ATTRIBUTABLE TO THE PATIENT'S SCLEROTIC BONE.

    Description of Event or Problem · 1

    ON 12.7.2017 IT WAS REPORTED TO K2M, INC. THAT A SURGERY TOOK PLACE IN WHICH THE DISTAL TIP OF AN SCREW INSERTER CRACKED CAUSING AN INCREASE IN SURGICAL TIME. SURGERY TOOK PLACE ON (B)(6) 2017. (RELATED TO 3004774118-2017-00219 AND 3004774118-2017-00220)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11981 EVEREST SPINAL SYSTEM PEDICLE SCREW SPINAL SYSTEM LXH K2M INC. FFRG

    Patients

    Seq Age Sex Outcome Treatment
    1