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 2019-04-04 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM SL-1700260 manufactured by Illuminoss Medical Inc..
[140962432]
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.
Patient Sequence No: 1, Text Type: N, H10
[140962433]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2019-00004 |
| MDR Report Key | 8484552 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-04 |
| Date of Report | 2019-04-04 |
| Date of Event | 2019-02-20 |
| Date Mfgr Received | 2019-02-22 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2019-04-04 |
| 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 | 2019-04-04 |
| Catalog Number | SL-1700260 |
| Lot Number | 380817 |
| 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 EATS PROVIDENCE RI 02914 US 02914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-04 |