BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST® SPINAL SYSTEM

    MDR report key: 8587103 · Received May 7, 2019

    Report

    Report Number
    3004774118-2019-00050
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    April 15, 2019
    Report Date
    July 16, 2019
    Manufacturer
    K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. UPON REVIEW OF THE SCREW INSERTER, IT WAS OBSERVED THAT THE HEXALOBE FEATURE AT THE DISTAL TIP WAS WORN. THIS DEFORMATION MAY PRESENT DIFFICULTY DURING DISENGAGEMENT.

    Description of Event or Problem · 0

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT THE TIP OF A LOCKING SCREW INSERTER SHAFT BENT/TWISTED INTRA-OPERATIVELY. (RELATED TO 3004774118-00049)

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION YET. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 1

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT THE TIP OF AN INSERTER INNER SHAFT BROKE INTRA-OPERATIVELY. THE TIP OF THE INSERTER SHAFT AND LOCKING SCREW INSERTER SHAFT REMAIN IN THE PATIENT. (RELATED TO 3004774118-2019-00049).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381969 EVEREST® SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION GUYU

    Patients

    Seq Age Sex Outcome Treatment
    1 3303-90152 LOT UNKNOWN| 3303-90152 LOT CJLU| 3303-90152, LOT UNKNOWN