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

Catalog Number USSL-2213160

Device Problem Fracture (1260)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

The manufacturer is in process of investigating this event, and will submit a followup report with investigation findings and conclusions, and any updated information.

Event Description

The patient had a broken right metastatic proximal humerus fracture which was treated with an illuminoss implant (ussl-2213160) on (b)(6) 2022.A few weeks after the initial surgery around (b)(6) 2022, the illuminoss implant broke at the fracture site.A revision surgery was performed on (b)(6) 2022 to remove the broken illuminoss implant and replace it with a new implant and add supplemental fixation using a plate and screws.After removing the illuminossimplant, the user felt that the initial implant was not inflated enough at the fracture site during the initial fixation surgery to keep the fracture reduced.

Manufacturer Narrative

At the time of the initial mdr submission for this event, the investigation into the cause of this event was still underway.This followup mdr is submitted to submit new information, including - the investigation findings codes - investigation conclusion codes - and this manufacturer's narrative with the firm's root cause conclusions.The firm reviewed the manufacturing records for this device, and found that it was in specification at the time of manufacture and release.No evaluation of the device was possible as it remained within the patient, however, pictures were provided of the removed implant for evaluation.Followup information from the user: the user provided x-rays to the firm.The user also communicated that after the implant removal revision surgery, they concluded that the initial implant was not inflated enough at the fracture site in order to provide enough strength to the keep the fracture reduced and stable.Internal medical oversight review: additional review of the information about the case, medical records, and x-rays was performed with medical oversight on november 10th 2022, to supplement the complaint investigation.Illuminoss clinical and medical affairs met with independent medical oversight and made the following observations: · in the initial post-op x-rays, the width of the implant at the fracture site is substantially smaller than the width of the rest of the implant and it does not appear to contact the cortical walls of the bone at the fracture site and just proximal to the fracture.The strength of the implant is reduced at the fracture site due to the decreased width compared to the rest of the implant.· the pictures of the removed implant also confirm that the implant had a section with a smaller diameter than the rest along the fracture site, which is the location where the implant broke.· the picture of the explanted implant was measured and the smallest diameter of the implant at the location of the break was estimated to be about 8mm in width.The widest part of the implant was estimated to be about 14mm in diameter.· the implant was not filled sufficiently to achieve cortical wall contact at the fracture site.· internal firm medical oversight agreed with the user's conclusion that the implant was too thin over the fracture site and lacking cortical wall contact in this area causing the implant to break.Surgical technique guide 900510_d includes the information that fracture stabilization cannot be assured when the illuminoss implant is not in contact with the cortical wall.This technique guide also notes that a minimum canal diameter of 13mm is required for the stand-alone use of the implant in load bearing indications, and instructs the user to utilize fda cleared plates in conjunction with the implant in those cases where the implant will not achieve 13mm in diameter in the area of the fracture.In this case, the implant was not able to achieve 13mm in diameter in the area of the fracture, nor was cortical wall contact observed with the implant at the narrowest portion of the implant, across the fracture site.The user's use of the illuminoss implant in this way, with a significant narrowing of the implant at the point of the fracture site, and without cortical wall contact there at the fracture site, are the cause for the implant break, as a result of use error.Conclusion the root cause of the implant break in this situation was due to insufficient filling of the implant, leaving it with a significantly narrow portion (well under 13mm) at the point of the bone fracture site, without sufficient contact with the bone's cortical wall.

• Brand Name: PHOTODYNAMIC BONE STABILIZATION SYSTEM
• Type of Device: IN VIVO INTRAMEDUILLARY FIXATION ROD
• Manufacturer (Section D): ILLUMINOSS MEDICAL, INC; 993 waterman ave; east provience 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: 15740177
• MDR Text Key: 303138052
• Report Number: 3006845464-2022-00015
• Device Sequence Number: 1
• Product Code: QAD
• 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,Followup
• Report Date: 12/09/2022

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 Catalogue Number: USSL-2213160
• Device Lot Number: 390621
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 12/09/2022
• 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 Age: 87 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Asian