MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-08 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM SL-1700260 manufactured by Illuminoss Medical Inc.
[141204302]
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.
Patient Sequence No: 1, Text Type: N, H10
[141204303]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2019-00005 |
| MDR Report Key | 8491703 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-08 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-02-13 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2019-04-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. ROBERT RABINER |
| Manufacturer Street | 993 WATERMAN AVE |
| Manufacturer City | EAST PROVIDENCE RI 02914 |
| Manufacturer Country | US |
| Manufacturer Postal | 02914 |
| Manufacturer Phone | 4017140008 |
| Manufacturer G1 | ILLUMINOSS MEDICAL INC. |
| Manufacturer Street | 993 WATERMAN AVE |
| Manufacturer City | EAST PROVIDENCE RI 02914 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02914 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM |
| Generic Name | IN-VIVO INTRAMEDULLARY FIXATION ROD |
| Product Code | QAD |
| Date Received | 2019-04-08 |
| Catalog Number | SL-1700260 |
| Lot Number | 380817 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ILLUMINOSS MEDICAL INC |
| Manufacturer Address | 993 WATERMAN AVE EAST PROVIDENCE RI 02914 US 02914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-08 |