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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN-VIVO INTRAMEDULLARY FIXATION ROD

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ILLUMINOSS MEDICAL INC. ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN-VIVO INTRAMEDULLARY FIXATION ROD Back to Search Results
Catalog Number SL-1700260
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Date 02/20/2019
Event Type  Injury  
Manufacturer Narrative
A review of the information detailing this incident as well as the radiographs of the implant, found no conclusive evidence of root cause.Probable root causes were discussed which included poor bone quality (osteoporotic bone-very thin), what appears to be a potential failure of a competitor's plate and screws used to secure the fracture, and the potential of not inflating the implant to the minimum diameter of 13mm at the fracture site to ensure effective load bearing strength.A review of the manufacturing records specific to the delivery kit and balloon assembly found no anomalies in the manufacturing process.Additionally, a review of the device history record of the timer key that was placed in this delivery kit that is used to control the amount of light needed to fully cure the infused monomer within the implant, was per specification.
 
Event Description
It was reported that a patient's illuminoss implant had fractured approximately 2 weeks after implantation.Report received on 22feb2019 that on (b)(6), dr (b)(6) needed to revise a fracture of the left humerus as a result of a small plate partially detached from the bone and a fractured illuminoss implant.The illuminoss device had been implanted along with a plate on (b)(6) 2019.The dr found that the illuminoss implant had fractured and the distal end of the small plate had detached from the patient's bone (screws pulled out of the bone).Dr (b)(6) proceeded to revise the fracture by leaving the broken illuminoss inside but removed the small plate.A larger angle-stable plate (humerus plate) was inserted and attached to the humerus.It was reported that dr (b)(6) had fixed the problem and the humerus was stable.Dr (b)(6) also indicated that the patient had very poor bone quality.The dr added that the patient had an infection prior to using the illuminoss implant.Prior to using the illuminoss implant, another company's metal nail had been used as the intramedullary support.After implanting the nail, the patient developed an infection.The nail was removed and replaced with the illuminoss device and small plate.It was reported that after the illuminoss product was implanted the infection cleared up.The dr also noted that the patient preferred sleeping on their side (also with the illuminoss implant).
 
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Brand Name
ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
Type of Device
IN-VIVO INTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
ILLUMINOSS MEDICAL INC.
993 waterman ave
eats providence RI 02914
Manufacturer (Section G)
ILLUMINOSS MEDICAL INC.
993 waterman ave
east providence RI 02914
Manufacturer Contact
robert rabiner
993 waterman ave
east providence, RI 02914
4017140008
MDR Report Key8484552
MDR Text Key140962432
Report Number3006845464-2019-00004
Device Sequence Number1
Product Code QAD
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K181228
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Expiration Date05/31/2022
Device Catalogue NumberSL-1700260
Device Lot Number380817
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/22/2019
Initial Date FDA Received04/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ILLUMINOSS DEVICE & COMPETITOR'S SCREWS/PLATES
Patient Outcome(s) Required Intervention;
Patient Age77 YR
Patient Weight80
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