BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRENEES® CERVICAL PLATE

    MDR report key: 7991251 · Received October 22, 2018

    Report

    Report Number
    3004774118-2018-00162
    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. INSPECTION OF THE RETURNED PLATE REVEALED MINIMAL DEFORMATION IN THE PROXIMAL AND DISTAL RETAINING HOLES. THE MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED AND NO RELEVANT DISCREPANCIES WERE FOUND.

    Description of Event or Problem · 0

    ON (B)(6) 2018 IT WAS REPORTED TO K2M, INC THAT A PLATE BACKED OUT, LOOSENED, DISENGAGED APPROXIMATELY 4-6 MONTHS POST-OPERATELY. PATIENT WAS REVISED ON (B)(6) 2018. ( RELATED TO 3004774118-2018-00161)

    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 A PLATE BACKED OUT, LOOSENED, DISENGAGED APPROXIMATELY 4-6 MONTH POST-OPERATIVELY. PATIENT WAS REVISED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830875 PYRENEES® CERVICAL PLATE ANTERIOR CERVICAL PLATE KWQ K2M. INC FNFV

    Patients

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