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Illuminoss sales rep received phone call from prof.Dr.(b)(6) on feb 3rd, 2021, reporting this complaint: an overweight patient with pathological humerus fracture in both arms was treated with illuminoss photodynamic bone stabilization systems.Both arms were treated on (b)(6) 2021.The fracture treatment did not utilize additional fixation, nor was post-operative external stabilization (e.G.A brace) used.On (b)(6) 2021, patient presented with broken implant on the right side after supporting herself with her arms.The patient reported pain when she moved up and down in her bed, and must use her arm or hand for deposition.The patient was then treated with an additional fixation plate, which was affixed to the pieces of the broken implant that remained implanted.The following information was collected and made available to the investigation team: product was not returned.Remains in patient.Radiographs - x-rays were provided by the treating physician and are retained in complaint file (b)(4).Validation testing of the product in question was reviewed: ens-1042 (biomechanical testing of illuminoss implants in a humerus cantilever bend model); white paper: orthopedics research and traumatology, volume 1 : issue 1, article ref.#: 1000ortoj1102, entitled "a biomechanical comparison of a novel expandable photodynamic intramedullary system to a metal plate and screw system in humerus and femur osteotomy models.Risk review: fmea-1002 rev.F (implants & disposable accessories) was reviewed, and complaint tend analysis was performed and found the product is performing within the anticipated risk profile of the device.The fmea captures this failure mode and its effects and causes as observed in this complaint, and the severity of this even is in line with anticipated severity.A review of 12 months of complaints with the observed failure mode "broken implant" for the cause "delayed union, nonunion, insufficient quantity or quality of bone, markedly unstable comminuted fractures, or insufficient initial fixation" found that the experienced occurence rate is in line with the anticipated occurence rate.Ifu review: 900535 rev b.Is the ifu for the illuminoss photodynamic bone stabilization system in europe.As this procedure was for fracture alignment reduction and the treatment of a pathological fracture of the humerus, the procedure is in line with approved indications for europe.(ref: 900535 rev.B ifu).Dhr review: a review of manufacturing records for this lot show that the lot met manufacturing specifications at the time of release.The investigation team requested and received the following additional information from the physician: q: was the intramedullary canal measured to ensure the correct balloon size was used?.A: yes.Both length and width of canal was measured.Q: was a sarmiento brace or other external support device used in conjunction with the illuminoss implant at time of treatment? a: no.The patient was bed-ridden.Q: was any additional treatment, post implant break, taken? a: yes.The humerus was then treated with an additional plate (additional x-rays provided by prof.Haering).Additional info provided: when they treated the patient with the additional plate they saw a huge bone defect which was not visualized in the xrays.Due to the metastases a large part of the bone was degraded.Q: was the patient reporting any pain on (b)(6) when the prof - dr took the second set of x-rays? a: she has had no acute pain like after a fresh fracture only when she moved in here bed up and down and must use her arm or hand for repositioning.Q: had this bone been irradiated prior to placing the illuminoss implant? a: no.There was no irradiation prior to the implantation of the balloon.This hospital will do the surgery and then irradiate after it is believed the bone has healed.Explanation- the soft tissues and the bone structure change in a way that they do not heal after radiation.They have had better experiences when they have not used radiation beforehand.Observations made by the illuminoss investigation team: x-rays revealed that it's the same fracture site before and after the implant break.Also, the quality of the bone did not look good.With any im fixation system or rod, there is a risk of fracture of the components or loss of fixation in bone, attributable to insufficient quantity or quality of bone or markedly unstable comminuted fractures, the product's ifu (p/n 900535 rev b) identifies this risk.Root cause analysis tool: 5-whys: q1 - what is the most likely cause for the implant break? a1 - loosening or loose of fixation of the implant q2 - what causes loss of fixation or loosening of the implant which was not ruled out during the investigation? a2 - the implant is not held sufficiently in place by the surrounding bone during the healing process q3 - what could cause the implant not to be held in place sufficiently? a3 - insufficient surrounding bone quantity, and/or poor surrounding bone quality, and/or lack of supplemental fixation or post-operative bracing device q4 - why was there no supplemental fixation method or post-operative bracing device used? a4 - surgeon determined that the patient's bone quantity and quality - combined with anticipated restriction of movement (bed-ridden) - did not require supplemental fixation or post-operative bracing at the time of placing the illuminoss implant treatment.Q5 - why did surgeon determine that patient's bone quantity and quality did not require supplemental fixation or post-operative bracing at the time of placing the illuminoss implant? a5 - after the fact, when the doctor was treating the broken implant with the additional plate, they saw a large bone defect which was not visualized in the xrays taken at the time of the initial illuminoss implant.Only during the open procedure to place the additional plate for fixation to address the broken implant was the doctor able to see that due to the metastases, a large part of the bone was degraded.Conclusion: given the information presented above, the most probable root cause of implant the break was insufficient bone quantity (large defect) and poor bone quality (degradation).In the initial patient evaluation the surgeon could not see the large bone defect associated with the metastatic disease, as it was not visualized on the x-rays.The doctor determined to treat a large, segmented fracture using the illuminoss implant without supplemental fixation or post-operative bracing support.The increased risk of implant break due to poor bone quality was not mitigated by surgeon's directed treatment, as the extent of bone degradation was not known at that time.Due to the weaker than expected bone quality, the implant needed to provide most of the strength needed to support the patient's weight anytime they put pressure on their arm, which led to the implant breaking.
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An overweight patient with pathological humerus fracture in both arms was treated with illuminoss photodynamic bone stabilization systems.Both arms were treated on (b)(6) 2021.The fracture treatment did not utilize additional fixation, nor was post-operative external stabilization (e.G.A brace) used.On (b)(6) 2021, patient presented with broken implant on the right side after supporting herself with her arms.The patient reported pain when she moved up and down in her bed, and must use her arm or hand for deposition.The patient was then treated with an additional fixation plate, which was affixed to the pieces of the broken implant that remained implanted.
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