MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-10-11 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM USSL-1700280 manufactured by Illuminoss Medical Inc.
[123956702]
Surgeon was trained the day prior to the procedure being performed. Surgical technique guide instructs users of the device that if adjustments of the balloon position or bone is required depressurize balloon by opening stopcock and aspirating monomer out of the implant. Attempts at repositioning a fully filled balloon may cause damage to the balloon. Physician attempted to adjust the bone position with the bone clamp during the cure cycle with fully inflated balloon. Physician acknowledged that they erred in attempting to readjust the bone.
Patient Sequence No: 1, Text Type: N, H10
[123956703]
This incident occurred during an off label use procedure. The user attempted to implant the device into the patient's femur. The intended use of this product is in the humerus/radius/ulner. The area above the femur was opened. The patient's hip prosthesis and plate were removed. The canal was reamed to 16-17mm. A 17x280mm implant was prepped and implanted into the femoral canal from the medial condyle. The implant was positioned across the fracture and filled with monomer. A bone clamp was used to hold the fracture together. The curing process was initiated and about 100 sec into the curing process the surgeon attempted to reposition the bone clamp and at that point the surgeon stated the bone clamp had perforated the balloon. The light box was turned off and monomer was suctioned from the balloon at the perforation site. The implant was removed from the canal easily. The site and canal were cleaned using suction/irrigation. A new 17x260 balloon catheter was prepped and implanted. The surgeon applied pressure to the fracture using a mallet to maintain reduction and the implant was successfully cured. As of september 19th, it was reported that the patient was doing ok and in recovery at the hospital. In addition to the balloon implant procedure which was 30-40 min in duration, there were additional procedures performed to remove a hip prosthesis and plate which took 2 1/2 hrs. Patient's hospital stay was due to these additional procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2018-00003 |
| MDR Report Key | 7958334 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-10-11 |
| Date of Report | 2018-10-11 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2018-04-25 |
| Date Added to Maude | 2018-10-11 |
| 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 |
| Remedial Action | PM |
| 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 | 2018-10-11 |
| Model Number | USSL-1700280 |
| Catalog Number | USSL-1700280 |
| Lot Number | 380427 |
| Device Expiration Date | 2019-06-30 |
| 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 AVE EAST PROVIDENCE RI 02914 US 02914 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-11 |