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This event is being reported as a serious injury report, for a medical intervention performed for a patient condition that presented after an implantation procedure with the manufacturer's device.Although the manufacturer's investigation (still ongoing) has not yet concluded that the need for medical intervention was due to the use of the manufacturer's device, this event is being reported out of an abundance of caution.On (b)(6) 2022, dr.(b)(6) of medical center (b)(6) treated a (b)(6) female for pathologic fracture of the pelvis, and planned to use three illuminoss photodynamic bone stabilization system implants [sized 1.22x100mm 2.13/10x90mm 3.13/10x90mm].After performing the implant curing process, one of these implants [the 13/10x90mm sized implant in the anterior column] was found under-cured.It was replaced with another implant [sized 13/10x120mm].The new implant was placed in the same location and was cured successfully, adding 20 minutes to the overall procedure time, and the patient outcome after this procedure was reported as good.On (b)(6) 2022, illuminoss was notified by the treating physician that there was a change in the patient condition.On (b)(6) 2022, illuminoss was notified of the additional treatment dr.(b)(6) rendered as a result.Dr.(b)(6) reported that the patient presented with a fever, swelling and red skin at the incision sites.The patient was hospitalized.An mri demonstrated fluid collections and edema collecting in the gluteus muscle.The patient was treated with antibiotics, and debridement and irrigation of the affected area of the lateral pelvis on the patient's right side.The patient had elevated white blood cell count.Pathology from the area was done and called it "foreign material".The pathology of the muscle was acute muscular inflammation.All cultures taken were negative for growth, ruling out infection.The patient remained hospitalized for the course of a few days, during which time patient presented as afebrile (without fever), and cultures taken were returned negative for infection.The patient returned home with continuing swelling in the gluteus medius area, and pain.In the weeks following, subsequent follow-ups with the treating physician on the patient condition noted that while the patient has remained at home and has made some improvements, she was "slow to recover" muscle function.The manufacturer's investigation is ongoing, and includes product evaluation of the returned device, medical review of radiographs and procedural imaging, and follow up communications with the treating physician.The device is expected to be returned to the manufacturer arriving on 19-may-2022.The manufacturer has completed a review of manufacturing records associated with this case, and found that the devices were within specification at the time of manufacture and release.
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Investigation activities: this complaint investigation used these information sources: returned product evaluation & additional bench top product testing, risk review fmea-1002 & pms analysis, manufacturing records review of the instructions for use and surgical technique guide, follow up interviews with the user, medical oversigh review of radiographs mris and ct scans, review of validation testing reports, this investigation used this information to determine and characterize the role of the illuminoss device in 3 specific areas: 1.What caused the curing failure? 2.Did monomer leak? 3.Did leaked monomer cause or contribute to the patient adverse event observed after the implantation procedure? returned product evaluation & additional product testing the two light boxes involved in the case were returned to illuminoss and the under-cured implant sent to exponent for decontamination before return to illuminoss.See attachment a for the full documentation and images of the returned product evaluation and additional product testing.In summary, product evaluation found the following: 1.Cause of the curing failure: the as found light fiber condition of the implant with the light fiber still inside provides information for the most probable cause of the curing failure.Product evaluation allowed us to eliminate the light box performance as the cause of this complaint.The condition of the light fiber, and its observable pattern of damage, indicate this as a likely contributor to the user's experience of insufficient curing.A damaged light fiber can reduce the amount of light delivered from the light box to the monomer, which can lead to insufficient curing.2.Presence of monomer leak: product evaluation confirmed there was a monomer leak, as monomer was found polymerized on the outside of the catheter (but not the balloon).However, the origin point of that leak could not be definitively determined, and the only identified possible egress point would have allowed a small amount of monomer to be leaked outside of the balloon during the monomer infusion process.Dhr review: a review of manufacturing records for the products involved, both the implant kit as well as the light boxes, was performed, and the devices met specification at the time of manufacture and release.See attachment b for the full dhr review performed.Followup interviews with user: additional follow-up information was gathered from the user and the illuminoss sales representative.It was reported that during the separation action performed for this implant, the user struggled to score the balloon adjacent to the bone.During the catheter separation attempt, the implant was accidentally pulled entirely out of the patient, and the user found that the implant was not cured.A new implant was placed into the canal and successfully cured.Upon reflection, the user and sales representative reported that the incision area and canal were not cleaned out or flushed between the accidental removal of the under-cured implant and before the placement of the 2nd implant was performed, and that they had concerns that liquid monomer could have leaked into the muscle tissue surrounding the anterior column if their removal actions on that first balloon had caused the implant to leak.Product evaluation of the returned implant and partial catheter (see below) confirmed the presence of monomer on the outside of the catheter, but no confirmed source for a monomer leak.During the irrigation and debridement treatment performed as medical intervention for the changed patient condition, dr.(b)(6) reported observing a gooey substance inside the incision site, that he removed first manually.Review of ifu and potential for user error: surgical technique guide 900598_a for the pelvis instructs the user if there is a potential egress of the liquid monomer into the medullary canal, to follow steps to remove the balloon catheter and clean the medullary canal of liquid monomer through aspiration, lavage, and swabbing, and once the canal is cleaning is finished, the surgeon may implant a new illuminoss device.In this situation, upon removal of an uncured implant suspected of leaking, the user did not clean out the liquid monomer in any way prior to implanting a new balloon, which is not per the instructions for use.This potential user error is captured in the product's risk documentation.Review of risk of patient tissue reaction to monomer: the investigation then focused on the role that a small amount of leaked monomer could have played in causing or contributing to the patient adverse event observed after the implantation procedure.The risk of adverse tissue reaction is captured in instructions for use, 900356_w as a risk that can occur as with any im fixation device "adverse tissue reaction, infection, including wound complications, soft tissue damage." in addition, the risk of skin sensitization due to contact with liquid monomer is captured: "the monomer in liquid form may cause sensitization by skin contact.In case of contact with skin, wash immediately with soap and water".There are instructions to clear liquid monomer if a balloon leak occurs in surgical technique guide for the pelvis 900598_a: "liquid monomer removal procedure: clean the medullary canal.Aspirate: apply a hospital-based suction line, thoroughly aspirate any residual monomer.Lavage: using a syringe, lavage the canal with sterile isotonic saline.Swab: with a small diameter sterile swab or pledget, insert the tip of the swab into the canal and advance and retract in a twirling fashion to clean and dry the medullary wall.(repeat: swab.) repeat the process with new swabs until in the opinion of the surgeon, the canal is free of any residual liquids, debris or other materials that were present.Once the canal cleaning is finished, the surgeon may repair and stabilize the fracture with a new illuminoss device." in this situation, a small amount of liquid monomer leaked at some point during the procedure and was present on the outside of the catheter, and likely in the patient's incision.The treating physician in this case did not clean out or flush out the incision between the accidental removal of the under-cured implant and before the placement of the 2nd implant was performed.Skin sensitization is a t-cell mediated delayed-type hypersensitivity reaction induced by low molecular weight reactive chemicals (allergens) comprising two phases, induction and elicitation.1 as stated in ifu 900356_w the monomer in liquid form may cause sensitization by skin contact.Illuminoss biological safety testing report rep-1038 describes the potential risk of skin sensitization by the liquid monomer due to an ingredient in the monomer, 2-hydroxyethyle methacrylate, which was determined to be a weak skin sensitizer in the guinea pig maximization test, and based on ambiguous human patch test results, has sensitizing properties and potential cross-reactivity with other acrylates.In rep-1038 the margin of safety for 2-hydroxyethyle methacrylate was calculated and supports the conclusion that the risk of induced toxicity from this ingredient in the illuminoss photodynamic bone stabilization system is very small.The sensitization tests on the implanted pin portion of the illuminoss device in rep-1038 found the product to be non-sensitizing per iso 10993-10.In humans skin sensitization is characterized by pruritis (itchy skin), erythema (superficial reddening of the skin), and oedema (fluid retention)1.(1: iso 10993-1:2021) in this situation the patient presented following the procedure with fever, swelling and red skin.The tissue cultures were negative, suggesting the reaction is not due to an infection.Debridement and irrigation were performed at the incision site of the implant that did not cure.The reported pathology of the area was muscular inflammation, the patient had increased white blood cell count and cellular debris at the area.An mri showed fluid collections and edema collections in the muscle.Some of these patient conditions are similar to a skin sensitization reaction, including the oedema of the area.The lack of positive cultures but increased white blood cell count suggests a tissue reaction as supposed to an infection.Illuminoss conducted a medical oversight review with dr.(b)(6) on (b)(6), 2022.At illuminoss medical's request, dr.(b)(6) provided illuminoss with the patient mri and ct scans of the affected area take from the day the patient presented with a changed condition ((b)(6) 2022).Illuminoss reconvened the medical oversight review with dr.(b)(6) on (b)(6), 2022, and determined the observed patient reaction is consistent with the expected response of a chemical exposure reaction or an allergic reaction.One of the contraindications of the illuminoss system is use in patients who are allergic to any of the implant materials or dental glue (900356_w).If the patient in this case was allergic to one of the implant materials or dental glue, it is possible this type of tissue reaction would occur when a sufficient enough quantity of liquid monomer is left behind in the tissue.Dr.(b)(6) also hypothesized that if it was a significant volume of liquid monomer left behind, the volume of that bolus may have contributed to the observed tissue reaction.Although the findings of the product evaluation conclude that the amount of monomer leaked outside of the implant was not a large volume, with what is known about this case at this time, we cannot rule out a patient allergic reaction or a sensitization reaction to the small amount of leaked monomer that was not flushed out of the incision at the time of the implantation procedure.In summary, it cannot be ruled out that the failure to clean out the small amount of liquid monomer from the incision site at the time of implantation could have led to the patient tissue reaction observed in this case, from prolonged tissue contact in the event that the patient was allergic or had a sensitization reaction.This is a known potential risk of the device, identified in the labeling.Investigation summary questions and answers: 1.What caused the curing failure? the light fiber damage (broken and kinked) observed in the returned implant is the most likely cause to the implant curing failure, which may have been caused by physical forces applied to the implant during insertion or placement.2.Did monomer leak? yes.Cured monomer was found on the outside of the returned implant catheter (but not the balloon).However, the origin point of that leak could not be definitively determined, and the only identified possible egress point would have allowed a small amount of monomer to be leaked outside of the balloon during the monomer infusion process.3.Did the monomer cause the observed patient tissue reaction? it is not definitively known.However, it cannot be ruled out that the failure to clean out the small amount of liquid monomer from the incision site at the time of implantation could have led to the patient tissue reaction observed in this case, from prolonged tissue contact in the event that the patient was allergic or had a sensitization reaction.This is a known potential risk of the device, identified in the labeling.Conclusion: the cause of the under cured implant is most likely due to light fiber damage sustained during implant insertion or placement.The cause of the observed patient tissue reaction is not definitively known, however it is possible it is attributable to a patient allergic reaction or sensitization reaction to the small amount of leaked liquid monomer remaining in the patient as the user did not clean out the liquid monomer at the time of the procedure, resulting in prolonged soft tissue contact and a resulting tissue reaction.
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This event is being reported as a serious injury report, for a medical intervention performed for a patient condition that presented after an implantation procedure with the manufacturer's device.Although the manufacturer's investigation has not definitely concluded that the need for medical intervention was due to the use of the manufacturer's device, this event is being reported out of an abundance of caution.On (b)(6) 2022, dr.(b)(6) of (b)(6) medical center in (b)(6) treated a 77-year old female for pathologic fracture of the pelvis, and planned to use three (3) illuminoss photodynamic bone stabilization system implants [sized 1.22x100mm 2.13/10x90mm 3.13/10x90mm].After performing the implant curing process, one of these implants [the 13/10x90mm sized implant in the anterior column] was found under-cured.It was replaced with another implant [sized 13/10x120mm].The new implant was placed in the same location and was cured successfully, adding 20 minutes to the overall procedure time, and the patient outcome after this procedure was reported as good.On (b)(6) 2022, illuminoss was notified by the treating physician that there was a change in the patient condition.On (b)(6) 2022 illuminoss was notified of the additional treatment dr.(b)(6) rendered as a result.Dr.(b)(6) reported that the patient presented with a fever, swelling and red skin at the incision sites.The patient was hospitalized.An mri demonstrated fluid collections and edema collecting in the gluteus muscle.The patient was treated with antibiotics, and debridement and irrigation of the affected area of the lateral pelvis on the patient's right side.The patient had elevated white blood cell count.Pathology from the area was done and called it "foreign material".The pathology of the muscle was acute muscular inflammation.All cultures taken were negative for growth, ruling out infection.The patient remained hospitalized for the course of a few days, during which time patient presented as afebrile (without fever), and cultures taken were returned negative for infection.The patient returned home with continuing swelling in the gluteus medius area, and pain.In the weeks following, subsequent followups with the treating physician on the patient condition noted that while the patient has remained at home and has made some improvements, she was "slow to recover" muscle function.
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