BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOTODYNAMIC BONE STABILIZATION SYSTEM

    MDR report key: 19906223 · Received August 5, 2024

    Report

    Report Number
    3006845464-2024-00020
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 5, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ILLUMINOSS MEDICAL INC.
    Product Code
    QAD
    PMA / PMN Number
    K181228
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTION WAS MAD TO THE DATE OF THE EVENT AND THE CATALOGUE NUMBER PERTAINING TO THE COMPLAINT. ROOT CAUSE INVESTIGATION FOLLOW UP INFORMATION THE DISTRIBUTOR PRESENT IN THE CASE STATED THAT THERE WERE NO VISIBLE BREAKS, KINKS OR DAMAGE TO THE LIGHT FIBER AND HE DID NOT WITNESS THE LIGHT FIBER CONTACT ANY SHARP OBJECTS. HE NOTED THAT THE DISTRIBUTORS PRESENT AND THE SURGEON NOTICED A POINT MIDWAY ALONG THE LIGHT FIBER IN WHICH THE LIGHT BEING ILLUMINATED VISIBLY DIMMED. THE SURGEON NOTED IT SEEMED LIKE THERE WAS A KINK AT THIS LOCATION ALONG THE LIGHT FIBER DUE TO THE VISIBLE CHANGE IN LIGHT BRIGHTNESS ALONG THE LIGHT FIBER, BUT THERE WAS NO VISIBLE KINK THEY COULD SEE. THE DISTRIBUTOR ALSO STATED THAT THERE WAS NOTHING VISIBLY WRONG WITH THE END OF THE LIGHT FIBER OR THE GOLD LIGHT HUB CONNECTOR. THE LIGHT BOX WORKED PROPERLY, BECAUSE AFTER THE UNDER CURED IMPLANT WAS REMOVED, A NEW IMPLANT WAS PLACED AND THE LIGHT FIBER CURED WITH THE SAME LIGHT BOX AND IT WAS NOTABLY BRIGHTER. DHR REVIEW: THE DHR OF LOT 440699 WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. ALL LIGHT FIBER ASSEMBLIES USED IN THIS LOT PASSED THE LIGHT FIBER INSPECTION TEST, DEMONSTRATING THE LIGHT OUTPUT WAS IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE DHR OF LIGHT BOX SN 660312 WAS REVIEWED AND FOUND TO BE IN SPECIFICATION AT THE TIME OF MANUFACTURE AND RELEASE. THE LIGHT OUTPUT OF THE LIGHT BOX AND LIGHT GUIDE WAS 366 MW/CM2 WHICH IS IN SPECIFICATION. RETURNED PRODUCT EVALUATION: THE IMPLANT WAS DISCARDED IN THE OR AND NOT ABLE TO BE RETURNED. IFU REVIEW IFU 900356_X STATES: THE MONOMER MUST BE EXPOSED TO THE ILLUMINOSS PHOTODYNAMIC CURING SYSTEM FOR A SPECIFIC AMOUNT OF TIME IN ORDER TO ACTIVATE AND FULLY CURE THE IMPLANT. SPECIFIC INSTRUCTIONS PROVIDED TO USER TO AVOID KINKING OR DAMAGING THE LIGHT FIBER BY CLAMPING OR CONTACTING WITH INSTRUMENTS, IN SURGICAL TECHNIQUE GUIDE 900477, 900510, 900523, 900524, 900598, 900602, 900604, 900611, 900780. POTENTIAL FOR USER ERROR THERE IS NO EVIDENCE THAT USER ERROR CAUSED THE COMPLAINT, HOWEVER INADVERTENT DAMAGE TO THE LIGHT FIBER BY THE USER CANNOT BE RULED OUT. THE DISTRIBUTOR STATED THERE WAS NO VISIBLE KINK OR DAMAGE TO THE LIGHT FIBER AND IT DID NOT CONTACT ANY SHARP OBJECTS. HOWEVER, BOTH THE DISTRIBUTOR AND USER OBSERVED A POINT ALONG THE LENGTH OF THE FIBER WHERE THE LIGHT OUTPUT FROM THE FIBER VISIBLY DIMMED, WHICH SUGGESTS A POINT OF DAMAGE RESULTING IN LESS LIGHT OUTPUT. IT IS POSSIBLE THAT THE LIGHT FIBER WAS INADVERTENTLY KINKED AND THEN STRAIGHTENED BACK OUT, RESULTING IN THE OBSERVED CHANGE IN LIGHT INTENSITY ALONG THE MIDSECTION OF THE LIGHT FIBER. CONCLUSION: THE MOST LIKELY CAUSE IS THE LIGHT FIBER WAS INADVERTENTLY KINKED DURING USE, RESULTING IN A DECREASE IN THE LIGHT TRANSMITTED FROM THE LIGHT BOX TO THE MONOMER AND THE UNDER CURED IMPLANT. AS THE LIGHT FIBER WAS DISCARDED AND NOT RETURNED FOR EVALUATION, AND THE DISTRIBUTOR PRESENT IN THE CASE COULD NOT VISUALLY SEE ANY KINKS OR DAMAGE TO THE LIGHT FIBER, THE DEFINITIVE ROOT CAUSE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS PENDING FURTHER INFORMATION.

    Description of Event or Problem · 0

    AN IMPLANT WAS INSERTED AND CURING STARTED, AND THE REPS NOTICED THAT THE BLUE LIGHT BEING EMITTED FROM THE LIGHT FIBER WAS NOT THE USUAL BRIGHT BLUE COLOR. BASED ON THIS, IT WAS THOUGHT THAT THE BALLOON DID NOT FULLY CURE, SO THE SURGEON CUT THE CATHETER AFTER THE CURING WAS OVER AND THE MONOMER STARTED SPILLING OUT. THE SURGEON PULLED THE BALLOON OUT AND REMOVED THE MONOMER, THE BALLOON REMAINED IN ONE PIECE. A NEW IMPLANT WAS INSERTED AND CURED WITH THE SAME LIGHT BOX AND THIS TIME THE LIGHT FIBER WAS BRIGHT BLUE AND THE IMPLANT FULLY CURED. THERE WAS A 50 MINUTE SURGICAL DELAY DUE TO THE CURING FAILURE.

    Description of Event or Problem · 0

    AN IMPLANT WAS INSERTED AND CURING STARTED AND THE REPS NOTICED THAT THE BLUE LIGHT BEING EMITTED FROM THE LIGHT FIBER WAS NOT THE USUAL BRIGHT BLUE COLOR. BASED ON THIS, IT WAS THOUGHT THAT THE BALLOON DID NOT FULLY CURE, SO THE SURGEON CUT THE CATHETER AFTER THE CURING WAS OVER AND THE MONOMER STARTED SPILLING OUT. THE SURGEON PULLED THE BALLOON OUT AND REMOVED THE MONOMER, THE BALLOON REMAINED IN ONE PIECE. A NEW IMPLANT WAS INSERTED AND CURED WITH THE SAME LIGHT BOX AND THIS TIME THE LIGHT FIBER WAS BRIGHT BLUE AND THE IMPLANT FULLY CURED. THERE WAS A 50 MINUTE SURGICAL DELAY DUE TO THE CURING FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2026987 PHOTODYNAMIC BONE STABILIZATION SYSTEM INTRAMEDULLARY FIXATION ROD QAD ILLUMINOSS MEDICAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention