BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MESA SPINAL SYSTEM

    MDR report key: 8462675 · Received March 28, 2019

    Report

    Report Number
    3004774118-2019-00030
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    March 6, 2019
    Report Date
    July 3, 2019
    Manufacturer
    K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION
    Product Code
    MNI
    PMA / PMN Number
    K143334
    Adverse Event
    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, IT WAS OBSERVED THAT ONE SCREW WAS IN THE LOCKED POSITION, WHILE THE OTHER WAS IN THE UNLOCKED POSITION. SIGNS OF CORROSION WERE VISIBLE ON THE INNER COLLET OF BOTH SCREWS, AND THE HEAD ASSEMBLY OF EACH SCREW WAS FIXED IN PLACE AND UNABLE TO ROTATE. IT WAS REPORTED THAT THE PATIENT FELL OFF A HORSE. MRI AND CT SCANS REVEALED THAT THE PATIENT HAD A VERTEBRAL BODY FRACTURE, WITH PROMINENT IMPLANTS AND BILATERAL PEDICLE SCREW POP-OUTS. IT IS LIKELY IMPACT FROM THE TRAUMA CAUSED THE VERTEBRAL BODY TO FRACTURE AS WELL AS CAUSED THE PEDICLE SCREWS TO DISENGAGE FROM THE RODS.

    Additional Manufacturer Narrative · 0

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT HAS BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS.

    Description of Event or Problem · 0

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT SCREWS BACKED OUT, LOOSENED DISENGAGED APPROXIMATELY 4-6 MONTHS POST-OPERATIVELY. THE PATIENT WAS REVISED ON (B)(6) 2019.

    Description of Event or Problem · 0

    ON (B)(6) 2019 IT WAS REPORTED TO K2M, INC. THAT SCREWS BACKED OUT, LOOSENED OR DISENGAGED APPROXIMATELY 4-6 MONTHS POST-OPERATIVELY. THE PATIENT WAS REVISED ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE SUBJECT PRODUCT WILL NOT BE RETURNED FOR EVALUATION. 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 SCREWS BACKED OUT, LOOSENED OR DISENGAGED APPROXIMATELY 4-6 MONTHS POST-OPERATIVELY. THE PATIENT WAS REVISED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255264 MESA SPINAL SYSTEM ORTHOSIS SPINAL PEDICLE FIXATION MNI K2M. INC, A SUBSIDIARY OF STRYKER CORPORATION EKHR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention