MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2019-04-11 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM USSL-2213220 manufactured by Illuminoss Medical Inc.
[145776041]
The device was not returned to illuminoss for evaluation. The final assessment of how the device fragmented was that it was due to excessive flexure and eventual fatigue failure as a result of a non-union of the bone where the implant was located, which was the expectation of the surgeon. Because of the non-union and the patient's physical therapy to relieve a frozen shoulder, the implant was subjected to stresses that may have contributed to the fragmentation of the implant. Please note this report is being resubmitted based upon correspondence with emdr staff. E\mdr was not able to be loaded of form was greater than 50 characters in length.
Patient Sequence No: 1, Text Type: N, H10
[145776042]
A fragmented implant was reported to an illuminoss employee on (b)(6) 2018, the report was of an implant that was surgically implanted into the humerus (b)(6) 2016 as part of the (b)(6) clinical trial. An adverse event for non-union in this patient was reported through the ide. The clinical trial has since been closed. The physician indicated that the fragmented implant was first detected on (b)(6) 2017 although this was not reported to the manufacturer. The current report is being made due to a recent correspondence with the physician in which it was reported to the company of the device fracture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2018-00004 |
| MDR Report Key | 8505453 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2019-04-11 |
| Date of Report | 2018-10-25 |
| Date of Event | 2017-05-15 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2016-01-15 |
| Date Added to Maude | 2019-04-11 |
| 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 | 3 |
| Brand Name | ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM |
| Generic Name | IN-VIVO CURED INTRAMEDULLARY FIXATION ROD |
| Product Code | QAD |
| Date Received | 2019-04-11 |
| Model Number | USSL-2213220 |
| Catalog Number | USSL-2213220 |
| Lot Number | 360050 |
| Device Expiration Date | 2016-12-31 |
| Operator | HEALTH PROFESSIONAL |
| 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 EAST PROVIDENACE RI 02914 US 02914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-11 |