MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-01-16 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM USSL-1700260 manufactured by Illuminoss Medical Inc..
[134585079]
The original surgeon responsible for implanting the illuminoss device is no longer at the hospital where the procedure occurred. The surgeon who is now caring for the patient in question, had inquired about the illuminoss device and whether they could drill into the device and revise the fracture, as they were unfamiliar with the implant material. Very little information has been obtained regarding the patient's current condition and whether a revision was done. Additional information is being requested.
Patient Sequence No: 1, Text Type: N, H10
[134585080]
A report was received on (b)(6) 2018 that an illuminoss implant had fractured post-operatively. It is unknown as to the cause or whether this issue was found during a routine follow-up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2019-00002 |
| MDR Report Key | 8254310 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-15 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2018-04-24 |
| Date Added to Maude | 2019-01-16 |
| 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 | 2019-01-16 |
| Catalog Number | USSL-1700260 |
| Lot Number | 380423 |
| Device Expiration Date | 2018-06-30 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ILLUMINOSS MEDICAL INC. |
| Manufacturer Address | 993 WATTERMAN AVE EAST PROVIDENCE RI 02914 US 02914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-16 |