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-2213220 manufactured by Illuminoss Medical Inc.
[134883850]
Implant date: (b)(6) 2018. It was reported that the case went well. After the monomer was cured, the operator drilled for and then inserted a zimmer 4. 0mm cannulated screw. It was later learned that the screw was placed through the implant at the fracture site. Illuminoss trainers instruct users to place screws through the implant at least 3cms or more, away from the fracture line.
Patient Sequence No: 1, Text Type: N, H10
[134883851]
Surgeon reported that a patient's implant had fractured. The patient had a fracture of the humerus with illuminoss implant and screw fixation. The surgeon also indicated that the fracture may have occurred within 6 weeks of the incident report date of (b)(4) 2018. It was noted by the surgeon that they had placed a 4. 0mm cannulated screw through the implant directly at the fracture line. They believe the implant did not expand to its fullest diameter where the screw was placed which may have weakened the implant. However, a review of the x-ray showed the implant nearly fully expanded. The implant fracture occurred where the screw went through it. It was noted that the screw was not centered in the implant. The surgeon reported that the patient was doing fine and the fracture was healing as expected with the illuminoss product still in place.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2019-00001 |
| MDR Report Key | 8254298 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-01-16 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-10-15 |
| Date Mfgr Received | 2018-10-31 |
| Device Manufacturer Date | 2018-04-02 |
| 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 CURED INTRAMEDULLARY FIXATION ROD |
| Product Code | QAD |
| Date Received | 2019-01-16 |
| Catalog Number | USSL-2213220 |
| Lot Number | 380340 |
| Device Expiration Date | 2019-06-30 |
| Device Availability | N |
| 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 | 2019-01-16 |