MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-06 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM USSL2213260 manufactured by Illuminoss Medical Inc.
[175182883]
Based on the review of the implant's dhrs which indicated no abnormalities with the manufacture of the balloon or catheter, and the review of the complaint description, it appears that the use of the rod pusher / high hat device as a means to move the balloon implant further down into the canal, may have contributed to the creation of a hole in the balloon. It is unclear how the pusher rod was used but any contact with the balloon could either damage it directly or force the balloon into the area of the fracture and against sharp bone fragments, causing a tear. Return of the device is expected. An investigation to confirm the above currently identified cause. This is the second attempt to submit this report. The initial attempt made on dec 6, 2019, failed due to the use of an incorrect device problem code.
Patient Sequence No: 1, Text Type: N, H10
[175182884]
On (b)(6) 2019, a procedure involving the fixation of the right humerus with the illuminoss implant was completed on a (b)(6) male patient. He was in stable condition throughout the procedure. In an effort to drive the implant more medial, the surgeon directed the fellow to use the rod pusher/high hat as a tool for such. Once they were more satisfied with the placement of the balloon, they began inflating. The inflation proceeded as expected. As the fellow approached the maximum inflation, it was noted that there it suddenly seemed to yield a bit. At this time, it was evident that monomer was oozing out of the insertion site. The fellow attempted to deflate the balloon. After filling one syringe and attempting to fill a second, due to an apparent hole in the implant, air was entering the syringe despite the implant not being fully deflated. At this time the implant was removed. A new implant was prepped, inserted, inflated, and cured without further issue. The incision was closed, and the patient was removed from the or suite without incident. The patient remained stable throughout the procedure which lasted approximately one hour and was resting comfortably after coming out of anesthesia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2019-00008 |
| MDR Report Key | 9554265 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-06 |
| Date of Report | 2019-12-06 |
| Date of Event | 2019-11-15 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2020-01-06 |
| 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 | INVIVO INTRAMEDULLARY FIXATION ROD |
| Product Code | QAD |
| Date Received | 2020-01-06 |
| Catalog Number | USSL2213260 |
| Lot Number | 390368 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-01-06 |