BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRENEES® SELF STARTING SCREW

    MDR report key: 7990762 · Received October 22, 2018

    Report

    Report Number
    3004774118-2018-00161
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    October 19, 2018
    Report Date
    September 13, 2018
    Manufacturer
    K2M. INC
    Product Code
    KWQ
    PMA / PMN Number
    K063544
    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 OF THE SCREW, IT WAS OBSERVED THAT THE INNER THREADS ON THE PROXIMAL END OF THE IMPLANT WERE HEAVILY DAMAGED/STRIPPED.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED O K2M, INC. THAT SET SCREWS BACKED OUT, LOOSENED, DISENGAGED APPROXIMATELY 4-6 MONTH POST-OPERATIVELY. PATIENT WAS REVISED (B)(6) 2018. (RELATED TO 304774118-2018-00162)

    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 09.13.2018 IT WAS REPORTED TO K2M, INC. THAT SET SCREWS BACKED OUT, LOOSENED, DISENGAGED APPROXIMATELY 4-6 MONTHS POST- OPERATIVELY. PATIENT WAS REVISED (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830829 PYRENEES® SELF STARTING SCREW SPINAL INTERVERTEBRAL BODY FIXATION ORTHOSIS KWQ K2M. INC FNTJ

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention 201-14016D LOT GDBP| 201-14016D LOT GFTK| 208-42F36 LOT FNFV| 208-42F36 LOT UNKNOWN| 208-42F36, LOT UNKNOWN