BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW SPINAL SYSTEM

    MDR report key: 6739436 · Received July 25, 2017

    Report

    Report Number
    3004774118-2017-00098
    Event Type
    Injury
    Date Received
    July 25, 2017
    Date of Event
    July 4, 2017
    Report Date
    July 7, 2017
    Manufacturer
    K2M, INC.
    Product Code
    NKB
    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. 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.

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. UPON RECEIVING FURTHER INFORMATION REGARDING THIS CASE, IT WAS DETERMINED THAT THE ISSUE WAS NOT CAUSED BY A K2M, INC., MANUFACTURED DEVICE. THE MANUFACTURER OF THE DEMINERALIZED FIBERS HAS BEEN NOTIFIED OF THE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A REVISION SURGERY TOOK PLACE WHEN PATIENT REPORTED LEFT LEG/FOOT PAIN. REVISION SURGERY TOOK PLACE (B)(6) 2017.

    Description of Event or Problem · 1

    ON 07.07.2017 IT WAS REPORTED TO K2M, INC. THAT AREVISION SURGERY TOOK PLACE WHEN PATIENT REPORTED LEFT LEF/FOOT PAIN. REVISION SURGERY TOOK PLACE (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521056 PEDICLE SCREW SPINAL SYSTEM NKB K2M, INC. 1613322-3010

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention