BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIREFLY

    MDR report key: 8488010 · Received April 5, 2019

    Report

    Report Number
    3011818499-2019-00001
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    December 20, 2018
    Report Date
    March 28, 2019
    Manufacturer
    MIGHTY OAK MEDICAL
    Product Code
    PQC
    UDI-DI
    00851662007001
    PMA / PMN Number
    K181399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DHR DID NOT FIND ANY DEVIATIONS OR ABNORMALITIES. REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS ON THIS ITEM FOR BREACHES RESULTING IN REVISION. REVIEW OF RETURNED PRODUCT DETERMINED THAT THE RETURNED PRODUCT WAS WITHIN SPECIFICATIONS. THE FINAL ROOT CAUSE DETERMINATION WAS IDENTIFIED TO BE USER ERROR IN PLACEMENT OF THE GUIDE. THIS ROOT CAUSE WAS CONCLUDED BASED ON DISCUSSIONS WITH THE SURGEON USING THE GUIDE, BONE MODEL AND POST-OP CT SCAN. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PATIENTS INITIAL POSTERIOR SPINAL FUSION OPERATION USING FIREFLY PATIENT-SPECIFIC PEDICLE SCREW GUIDE, WHILE USING THE L4 GUIDE ON THE L4 LEVEL IN THE PATIENT, THE LEFT SCREW WAS PLACED LATERALLY AND THE RIGHT SCREW WAS PLACED MEDIALLY. FURTHERMORE, THE PATIENT PRESENTED WITH PAIN AND RADICULOPATHY TWO WEEKS POST-OP AND REQUIRED A REVISION PROCEDURE TO REPOSITION THESE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279206 FIREFLY PATIENT-SPECIFIC PEDICLE SCREW GUIDE PQC MIGHTY OAK MEDICAL FF-101-XX 18PAHK 00851662007001

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention