MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM; INTRAMEDULLARY INVIVO FIXATION ROD

Catalog Number USSL-1700220

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 07/27/2020

Event Type  Injury  

Manufacturer Narrative

The patient involved presented with a fracture of the mid-humerus.The fracture was treated with a 17mm x 220mm balloon catheter on (b)(6) 2020.On (b)(6) 2020, the patient's arm with the implant, was x-rayed and the implant was found to be broken.Based on the details provided by the attending physician who implanted the illuminoss device, as well as analysis of radiographs taken of the broken implant by device experts from illuminoss, the most likely cause of the fractured illuminoss implant was due to excessive trauma to the arm with the implant, shortly after implantation.It was reported that the patient, while emerging from anesthesia and still intubated and still in their hospital bed, began flailing their arms.It is believed that the arm with the implant, may have come in contact with a hard surface creating impact forces sufficient to break the implant.Cause of the flailing may have been due to severe head trauma suffered by the patient at the time their arm was broken.An attempt was made on august 26, 2020 to submit this report but was unable to as the password to webtracker was not working.A request was sent to the esg help desk on august 26, 2020.Ticket # 237419 was opened.As a result, this report is being sent on august 27, 2020.

Event Description

On (b)(6) 2020, a procedure involving the fixation of the right humerus with the illuminoss implant and was completed on a (b)(6)-year-old female patient with bilateral humeral fractures and a traumatic brain injury.An illuminoss implant, ussl-1700220, was used to pin the fracture.It was supplemented with two synthes screws, one proximal to and one distal to the fracture.We were informed that the patient had fractured the implant at the initial fracture site the day following her procedure.The patient, still intubated, was non-compliant and excessively and violently flailing and bucking.Upon further imaging studies, it was confirmed that the implant was fractured.A revision procedure was performed on (b)(6) 2020 whereby a portion of the illuminoss implant distal to the fracture site was removed.Two synthes plates were applied without incident.In addition to the revision of the right humerus, the left humerus was pinned with a zimmer 9x160mm affixus® natural nail®, 47-2496-161-09.

Manufacturer Narrative

Due to an issue with the signing certificate password required to submit this mdr via the webtrader portal, this report was submitted on august 28, 2020 instead of august 26, 2020.The passward issue was corrected on august 28.The issue was first made known to the esg help desk on august 26, 2020.

Event Description

On (b)(6) 2020, a procedure involving the fixation of the right humerus with the illuminoss implant and was completed on a 19-year-old female patient with bilateral humeral fractures and a traumatic brain injury.An illuminoss implant, ussl-1700220, was used to pin the fracture.It was supplemented with two synthes screws, one proximal to and one distal to the fracture.We were informed that the patient had fractured the implant at the initial fracture site the day following her procedure.The patient, still intubated, was non-compliant and excessively and violently flailing and bucking.Upon further imaging studies, it was confirmed that the implant was fractured.A revision procedure was performed on (b)(6) 2020 whereby a portion of the illuminoss implant distal to the fracture site was removed.Two synthes plates were applied without incident.In addition to the revision of the right humerus, the left humerus was pinned with a zimmer 9x160mm affixus® natural nail®, 47-2496-161-09.

• Brand Name: ILLUMINOSS PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: INTRAMEDULLARY INVIVO FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC; 993 waterman ave; east providence, ri
• MDR Report Key: 10467898
• MDR Text Key: 204986011
• Report Number: 3006845464-2020-00004
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: 210331380231RX
• UDI-Public: 01210331380231RXI
• Combination Product (y/n): N
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: USSL-1700220
• Device Lot Number: 380231R
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ILLUMINOSS DEVICE
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR
• Patient Weight: 87