MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-03-06 for ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM SY-2000-01 N/A manufactured by Illuminoss Medical Inc..
[141472455]
The issue that caused the complaint was a displaced light bulb inside our light box. The light bulb emits a specific wavelength of light at a specific level of intensity for a specific period of time in order to cure the monomer material infused into an implanted balloon device. Once the curing time has been achieved, the monomer becomes a polymer and hardens creating a rigid pin within the intramedullary canal of the bone. In this particular case, this did not occur due to the light bulb within the light box, being displaced as a result of loosening of the screws used to hold the light bulb in place. Because the light box is a durable goods device it will be exposed to vibrations caused by shipping the device from hospital location to hospital location. It is these vibrations that are being considered the most probable root cause of the screws loosening and the eventual displacement of the light bulb. To provide context for this complaint, this is the first and only incident of a light bulb being found displaced, since the light box was first placed on the market in europe in 2010.
Patient Sequence No: 1, Text Type: N, H10
[141472456]
Complaint: monomer with the implant did not cure after the prescribed curing time was completed. Implant needed to be removed and replaced with another manufacturers nail. Details of procedure: female patient with lesion of unknown origin in right mid-shaft humerus was scheduled for im nail implant with illuminoss photodynamic bone stabilization system. The compromised bone was in an advanced state causing the bone to fracture during the prepping and positioning portion of the case preoperatively. The physician gained a minimally invasive access point just lateral to the rotator cuff structures on the right humerus per our procedure guidelines. The physician followed all prescribed procedural steps per the surgeons guide, to prepare the bone canal and the insertion of the implant. Monomer was infused into the balloon implant until the physician met resistance and could no longer infuse more monomer. Images were taken and implant position was verified prior to activation of the light source. The light fiber was handed off the sterile field and inserted into the light guide prior to activating the light box. The light box was set to the proper timing based upon the time card inserted. The foot pedal switch was activated to start the curing process. The curing process ran its course for 1,000 seconds and the light box deactivated at the completion of the time. The physician completed the final steps and upon separation of the tail, they noted that liquid monomer began to ooze out of the proximal incision site. The surgeon determined the implant did not fully cure and decided to remove the entire balloon implant. An approximately 6-inch incision was made on the lateral aspect of the upper arm to gain access to the active fracture site. The balloon implant was separated in two and the proximal portion of the implant was removed from the im canal. The physician removed the distal portion of the balloon from the distal humerus. The physician then took steps to place a synthes intermedullary nail. The case was complete and the patient incision closed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006845464-2019-00003 |
| MDR Report Key | 8394041 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-03-06 |
| Date of Report | 2019-02-25 |
| Date of Event | 2019-01-30 |
| Date Mfgr Received | 2019-01-30 |
| Device Manufacturer Date | 2016-02-01 |
| Date Added to Maude | 2019-03-06 |
| 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 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM |
| Generic Name | INVIVO INTRAMEDULLARY FIXATION ROD. |
| Product Code | QAD |
| Date Received | 2019-03-06 |
| Returned To Mfg | 2019-02-04 |
| Model Number | SY-2000-01 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2019-03-06 |