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

Catalog Number SL-2213240

Device Problem Malposition of Device (2616)

Patient Problem Implant Pain (4561)

Event Date 05/10/2023

Event Type  Injury  

Manufacturer Narrative

A company representative received a communication from a patient with questions about the illuminoss device and procedure, within which they described their condition, treatment with illuminoss, and subsequent pain and revision surgery to mitigate that pain.The patient reported: implantation date: (b)(6) 2023.Patient experienced continuous pain in the shoulder joint in the months following the operation: revision surgery was performed on (b)(6) 2023, during which a small piece of material 6-9mm in diameter and 6 mm high was removed from the head of the humerus, which the patient reports was determined by a treating physician as the cause of the pain.The patient provided additional x-rays taken from after the revision surgery the patient shared that they have other pre-existing medical conditions including multiple meyloma, a large osteolysis that developed in the upper left arm, that led to a fracture of the upper arm that was treated with the illuminoss implant and 2 screws.Illuminoss responded and requested additional information regarding the implantation surgery as well as the revision surgery they described.Illuminoss inquired if the patient would consent to us contacting their treating physicians about the case.The patient provided illuminoss with some of the information requested, including x-rays and a photograph of the material that was removed during the revision surgery in (b)(6) 2023.In answer to illuminoss' query, the patient declined to provide the name(s) of the treating physicians that performed the original illuminoss implantation, and/or the revision surgery.Based on the patient's response, no attempt was made to contact the treating physician.Returned product evaluation: returned product evaluation was not possible as the device remains implanted, and the material that was removed in the (b)(6) 2023 procedure was not made available by the patient for return, nor did patient consent to illuminoss contacting their doctor(s) directly.Dhr review: review of manufacturing records was not possible as the patient did not have the lot information of the device used, nor did they consent to illuminoss contacting their doctor(s) directly.Review of ifu: the device labeling 900535_c was reviewed and found to include the risk of soft tissue damage, pain, and revision.Medical oversight review: the firm performed an internal medical oversight review of this case, information received from the patient, and the radiographs provided.The following observations were made: the fracture appears to have healed.Implant position and alignment look good.X-rays appear to show evidence of calcific tendinitis.Calcific tendinitis is not near the entry point for the illuminoss implant, nor where the material was removed in the revision surgery.Medical oversight agreed with the assessment from the treating physician as reported to illuminoss by the patient, that bursitis is suspected.Examination of the x-rays from (b)(6), along with the photograph of the material removed during the (b)(6) revision surgery, support the conclusion that in (b)(6) 2023 the implant may have been placed and cured in position leaving a small portion of the proximal end of the implant protruding slightly through the bone at the point of entry, and that the material removed during the revision surgery in (b)(6) 2023 is likely a small portion of the cured implant from the pathway.The patient could have been feeling calcific tendinitis as the initial pain, and/or the potentially slightly protruding proximal end of the implant might have been a cause of pain.As the patient declined to consent to the firm contacting the treating physician(s), the medical evaluation of the initial implant placement, and the medical determination of the cause of the patient's pain could not be requested from the doctor(s) as a follow up.Conclusion: the pain experienced may have been caused by the material that was removed, or may have been caused by calcific tendinitis.A review of the x-rays supports the assessment that the implant was cured in a position where a small portion of the cured implant protruded slightly from the bone hole, which is likely the small piece of material which was removed from the humeral head in the revision surgery.As the patient did not consent to the firm contacting the treating physician(s), the specific cause for the implant having been cured in this position could not be determined with the information known.

Event Description

From a case in germany: a patient with a pathologic humerus fracture was treated with illuminoss implant and screws in (b)(6) 2023.The patient had pain in the shoulder following the operation.Revision surgery to address the pain was performed in (b)(6) 2023 during which a small piece of material was removed from the implant site.

• 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 (Section G): 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: 17504127
• MDR Text Key: 320863325
• Report Number: 3006845464-2023-00039
• Device Sequence Number: 1
• Product Code: QAD
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SL-2213240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Male