MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM USSL-1700220 manufactured by Illuminoss Medical Inc.
[124992846]
Surgeon reported that the light fiber was plugged into machine at too acute of an angle and may have led to the failure. The light box was repositioned in a different location in operating room (or) in the second implant cured completely at 1200 seconds. Status of the patient is in good condition, went home post op (day of surgery). Please note this report is being resubmitted based upon correspondence with emdr staff.
Patient Sequence No: 1, Text Type: N, H10
[124992847]
Case involving a (b)(6) male with left humerus, mid shaft fracture. The product was a 17 x 220 mm implant. The implant was place but then drained and removed in order to secure a biopsy. The implant was reinserted re-inflated and then cured. Approximately 2 minutes into curing some action by the medical staff caused the light fiber to break. An attempt to remove the original light fiber was made, towards inserting another fiber and continuing the curing cycle. Only a portion of the light fiber was able to be removed, which precluded the continuation of the curing cycle. An attempt to remove the monomer from the partially cured implant was made, by piercing the implant and aspirating some of the monomer. Some of the monomer was removed in this fashion, although not a significant amount. The original implant was attempted to be removed from the canal by pulling on the catheter, but was not able to be dislodged. A second implant 22/13 x 160 was delivered alongside the original implant. The second implant was infused with monomer. The expansion of the second implant caused the residual monomer in the first now pierced implant to be expelled through the pathway in the humeral head and removed. The second implant was cured for 1200 seconds. This represented an additional 400 seconds required for the second implant. The reason was to ensure curing of any residual monomer retained from the initial implant. There was no adverse event to the patient. However, the procedure was extended in time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2018-00002 |
| MDR Report Key | 7953117 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-08-09 |
| Date Mfgr Received | 2018-08-09 |
| Device Manufacturer Date | 2018-03-29 |
| Date Added to Maude | 2018-10-10 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM |
| Generic Name | ILLUMINOSS SYSTEM |
| Product Code | QAD |
| Date Received | 2018-10-10 |
| Model Number | USSL-1700220 |
| Catalog Number | USSL-1700220 |
| Lot Number | 380231 |
| Device Expiration Date | 2019-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 2 YR |
| 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. Other | 2018-10-10 |