BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIREFLY

    MDR report key: 11508611 · Received March 17, 2021

    Report

    Report Number
    3011818499-2021-00001
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    October 27, 2020
    Report Date
    March 16, 2021
    Manufacturer
    MIGHTY OAK MEDICAL
    Product Code
    PQC
    UDI-DI
    00851662007001
    PMA / PMN Number
    K181399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY & CONCLUSION: REVIEW OF DHR DID NOT IDENTIFY AND DEVIATIONS OR ABNORMALITIES. REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY ADDITIONAL COMPLAINTS ON THIS ITEM FOR LOSS OF MOTORS. THE 20ADAN SPINE ASSEMBLY A1 CAD FILE WAS DOWNLOADED AND INSPECTED. VISUAL INSPECTION OF THE GUIDE IDENTIFIED 6 PATIENT CONTACTING LOCATIONS (2 FIXATION SCREWS, 2 LEGS, AND 2 DISTAL EXTENSIONS) TO GUIDE 3 SCREWS (T7 L&R AND T7 L HEMI). INSPECTION OF THE PLANNED TRAJECTORIES IDENTIFIED THAT BOTH T7 SCREWS WERE AGAINST THE MEDIAL WALL OF THE PEDICLE BUT NOT BREACHING. ALL SCREWS WERE PLANNED IN AN ACCEPTABLE LOCATION PER THE WORK ORDER FULFILLMENT PROCESS. INSPECTION OF THE CAD FILES FOR THE GUIDES & SCREWS FOUND THAT THE GUIDE WAS CONFORMING. THE BONE MODEL AND GUIDE WERE MANUFACTURED USING AN INTERNAL PRINTED AND INSPECTED. THE PARTS WERE ABLE TO PASS RELEVANT MANUFACTURING INSPECTION CHECKS (FF-PSG-507) TO STABILITY AND TRAJECTORY. NO EVIDENCE OF NONCONFORMANCE IDENTIFIED. LOSS OF MOTORS MAY BE DUE TO A VARIETY OF DIFFERENT REASONS. BASED ON THIS, A ROOT CAUSE FOR THE LOSS OF MOTORS CANNOT BE DEFINITIVELY CONCLUDED. BASED ON INFORMATION RECEIVED FROM THE CUSTOMER, THE SURGEON DID NOT BELIEVE HE HAD SEATED THE GUIDE APPROPRIATELY AND MEDIALLY BREACHED. WITHOUT RADIOGRAPHS, A MEDIAL BREACH CANNOT BE CONFIRMED. ALL EVIDENCE INDICATED THAT THE GUIDE PROVIDED TO THE CUSTOMER WAS CONFORMING. IT CANNOT BE CONFIRMED OR REFUTED THAT THE GUIDE CAUSED OR CONTRIBUTED TO THE PATIENT INJURY.

    Description of Event or Problem · 1

    EVENT DESCRIPTION AS EVALUATED: DURING AN INITIAL POSTERIOR SPINAL FUSION SURGERY UTILIZING FIREFLY GUIDES, A PATIENT LOST MOTORS DURING THE PROCEDURE. THE PROCEDURE WAS STOPPED AFTER LOSS OF MOTORS AND ALL HARDWARE WAS REMOVED. THE PATIENT RECOVERED MOTORS AFTER THE PROCEDURE. THE PROCEDURE WAS CONTINUED AND COMPLETED APPROXIMATELY FOUR MONTHS LATER WITH NO ISSUES AND A SUCCESSFUL OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404534 FIREFLY PATIENT-SPECIFIC PEDICLE SCREW GUIDE PQC MIGHTY OAK MEDICAL FF-101-XX 20ADAN 00851662007001

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other| R