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The following information was collected and analyzed:
manufacturing dhrs.Follow up information from the doctor.Radiographs.Review of the instructions for use.Information provided by the doctor:
the patient had metastatic rcc (renal cell carcinoma) with an impending fracture of the clavicle, however a ct on january 24, 2022 showed a crack in the clavicle and based on the significant pain the patient was in, the user believes the clavicle had fractured and was no longer impending.On february 2, 2022 the patient had surgery, first with open curettage to remove as much rcc tumor as possible to prevent progression, then the user attempted to place the illuminoss implant laterally without much success.Instead, the user performed a retrograde pin from the fracture side laterally, reduced the fracture and shot the implant across the fracture site and inflated the implant under direct visualization.On february 26, 2022 a post-op diagnostic ct was taken and the implant and clavicle were discovered broken and displaced.The patient was unaware of the broken implant and in no pain.There is no revision surgery planned currently as if the patient's systemic treatment works, her bone can heal around the implant, despite it being displaced.There were no known accidents, falls or other situations which would cause unusual forces on the patient or implant.The clavicle was not radiated prior to surgery and the patient had no post-op additional stabilization or restrictions.Dhr review:
a review of the manufacturing records found that the device was in specification at the time of manufacture and release and there is no indication manufacturing contributed to this complaint.Illuminoss medical oversight review:
on march 10, 2022 illuminoss performed a medical oversight review of this case, followup information received from the doctor, and radiographs provided.It was observed that the medullary canal of the clavicle is very small, with the midpoint being about 3.5mm in width.There are significant forces on the clavicle, even with normal activity, such as a patient getting out of a chair and using their arms to push up.There are also significant cantilever forces on the clavicle from the arm.The diagnostic ct of the clavicle 24 days post op show the implant in what appears to be a zig-zag pattern, where the medial and lateral portions of the bone and implant appear intact and straight and the middle portion where the fracture is forms a zig-zag.Based on this ct the implant appears broken or bent at the fracture site and the clavicle is displaced.A follow up medical oversight review meeting was held on march 31, 2022 to discuss the additional case information gathered regarding the curettage of the tumor and retrograde pin method used.The user stated they performed open curettage before instrumentation to remove "as much tumor as humanly possible to prevent progression." illuminoss medical oversight noted that when you curette out a tumor such as the one in this case, you may leave a gap at the fracture site, depending on how much tumor was resected.Looking at images of the x-rays provided, illuminoss medical oversight noted the user curetted our portions of the clavicle canal and the cortex.In a pre-op image, it was observed the cortex of the clavicle is somewhat gone and it is bulged out due to the tumor, so to remove as much of the tumor as possible, the user would have had to remove about 2cm of cortex bone.On another image was observed sharp edges of cortex on the medial fragment and semi-sharp edges on the lateral fragment.Illuminoss medical oversight concluded it is likely the curettage removed a portion of the cortical bone and then the user pushed the remaining pieces of bone together, and the fracture site is missing about 1cm in length of bone.There is most likely a large nonviable cortex defect about a centimeter in length at the fracture site due to the curettage performed.It was also noted the acromioclavicular joint is displaced in the images after surgery and the clavicle is subluxated, compared to the pre-op images.Illuminoss medical oversight concluded the failure of the implant was likely caused by the cortical bone defect created by the curettage, which may have been closed when the implant was placed by pushing the two bone fragments together, but the weight of the shoulder opened the gap back up, and the small diameter implant broke or bent forming the "z" shape as it was unable to withstand the biomechanical forces of the clavicle with the bone defect.Additionally, the investigation team noted that the available evidence in the form of the images provided by the user show that the illuminoss implant is either bent, or broken.Review of ifu:
the use of the illuminoss implant is indicated for use in the clavicle in the us per the instructions for use, 900356_w, and the loss of reduction and implant bending that occurred in this situation is a known risk identified in this ifu "as with any im fixation system or rod the following can occur: loosening, bending or mechanical failure of the components attributable to insufficient quantity or quality of bone."
conclusion
the likely cause of the loss of fracture reduction and broken or bent implant is due to the gap in the bone created during curettage of the tumor which caused a large nonviable cortical defect and due to biomechanical forces of the clavicle, resulting in a loss of reduction and implant break/bend after surgery.
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