MAUDE Adverse Event Report: ILLUMINOSS MEDICAL INC PHOTODYNAMIC BONE STABILIZATION SYSTEM; IN VIVO INTRAMEDUILLARY FIXATION ROD

Model Number USSL-2213260

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism/Embolus (4438)

Event Date 07/28/2022

Event Type  Death  

Manufacturer Narrative

Background: on (b)(6) 2022 dr.(b)(6) was performing a distal femoral implant on a 78 year old female trauma patient.While the implant was curing, the patient expired.The patient was very sick with pre-existing medical condition, and it was noted that the patient had not been medically cleared for surgery the day before the procedure.The procedure progressed without any product malfunction or deviation from the manufacturer's instructions for use.The anesthesiologists observed that the patient's decline began and progressed so rapidly that it suggested a potential fat embolism as the cause.Dhr review: a review of manufacturing records for the product involved in this complaint was performed, and found the product met specifications at the time of manufacture and release.Returned product evaluation: the device remained implanted, and was not returned for evaluation.Root cause investigation: follow-up interviews with the illuminoss rep were performed regarding the procedure.The rep reported the steps performed by the treating physician to prepare the bone canal, prepare the implant, place the implant, and start the curing process were per the manufacturer's instructions for use, without product failure or malfunction.The rep's report indicates that the procedure was performed per the manufacturer's instructions for use, and that the illuminoss products performed as intended.Illuminoss director of qa called the treating physician dr.(b)(6) with follow up questions.During this interview, dr.(b)(6) provided confirmation that the patient was very ill with pre-existing medical conditions (he mentioned diabetes, dialysis, and heart problems specifically, in the context of stating that there were many), and confirmed the patient had not been medically cleared for surgery the day before the procedure.Dr.(b)(6) did not report any device malfunction or deviation from the manufacturer's instructions for use.Dr.(b)(6) concluded that he didn't know what caused the patient's death, but did share that the anesthesiologists observed that the patient's decline began and progressed so rapidly that it suggested a fat embolism as a potential cause.However, dr.(b)(6) concluded that the cause of the patient death was unknown.No autopsy was performed.Although dr.(b)(6) offered to share the op notes from this procedure during the interview on (b)(6) 2022, and indicated to company representative will irvine on (b)(6) 2022 that he would do so, at the time of this investigation report these notes have not been received.The root cause of the patient death in unknown, but could be the result of a thromboembolic event from a blood clot, contributed to by the patient's pre-existing medical conditions, or a fat embolism resulting from the fracture or the im fixation procedure to treat it.Thromboembolic events and fat embolisms that could result in organ damage or failure are known risks of im fixation procedures, which are included in the product labeling.The treating physician communicated that the patient was in a poor state of health at the time of the procedure, and reported no device malfunction or deviation from the manufacturer's instructions for use.No autopsy was performed, an no further information from the medical practitioner has been received.There is no indication that this event was a result of malfunction, failure, or change in the characteristics or performance of the device.Review of ifu, surgical technique guide and potential user error a review of us implant ifu (b)(4) rev.W was performed.There is no indication that the user deviated from the manufacturer's instructions for intended use of the product.The ifu contains the risk that "as with any im fixation system, the following can occur: thromboembolic event or fat embolism (blood clot, fat, or other material that could result in organ damage or failure)".Conclusion: the root cause of the patient death in unknown, but could be the result of a thromboembolic event from a blood clot, contributed to by the patient's pre-existing medical conditions, or a fat embolism resulting from the fracture or the im fixation procedure to treat it.The risks of thromboembolic event and fat embolism which can lead to organ damage or failure are known risks of im fixation procedures, and these risks are captured in the device labeling.There is no indication that this event was a result of malfunction, failure, change in the characteristics or performance of the device, or device mis-use.

Event Description

On (b)(6) 2022 dr.(b)(6) was performing a distal femoral implant on a 78 year old female trauma patient.While the implant was curing, the patient expired.The patient was very sick, with pre-existing medical conditions, and it was noted that the patient had not been medically cleared for surgery the day before the procedure.The procedure progressed without any product malfunction or deviation from the manufacturer's instructions for use.The anesthesiologists observed that the patient's decline began and progressed so rapidly that it suggested a potential fat embolism as the cause.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL INC; 993 waterman ave; east providence RI 02914
• Manufacturer Contact: robert rabiner ; 993 waterman ave; east providence, RI 02914 ; 4017140008
• MDR Report Key: 15216168
• MDR Text Key: 297767509
• Report Number: 3006845464-2022-00005
• Device Sequence Number: 1
• Product Code: QAD
• UDI-Device Identifier: M986USSL22132600
• UDI-Public: M986USSL22132600
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: USSL-2213260
• Device Catalogue Number: USSL-2213260
• Device Lot Number: 411150
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Asian