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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 01/31/2019
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.Most probable root causes were discussed which included fracture misalignment during the implantation of the illuminoss device, added stress on the implant due to patient weight which was reported as (b)(6) 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.An illuminoss product specialist reported the following on 14feb2019 from dr.(b)(6): prof.Dr.(b)(6) informed the product specialist on 02-13-19 / 10.43 a.M., that an illuminoss implant had broken within a few weeks of implantation.The implantation date was (b)(6) 2019.The patient told the dr.That he had not sat up or fallen.As a result of the break, a revision was necessary and took place on (b)(6) 2019.Prof.(b)(6) removed a part of the illuminoss implant because he had to reposition the bone in a way that required its removal.After reducing the fracture, was treated with a plate and screws for additional stability.
 
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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
east 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 Key8491703
MDR Text Key141204302
Report Number3006845464-2019-00005
Device Sequence Number1
Product Code QAD
UDI-Device Identifier22053138081M
UDI-Public0122053138081M
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 Health Professional
Device Expiration Date05/31/2022
Device Catalogue NumberSL-1700260
Device Lot Number380817
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/13/2019
Initial Date FDA Received04/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/13/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ILLUMINOSS DEVICE
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight140
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