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Donor file, donor eligibility records: the donor charts revealed no additional reports of adverse reactions involving any other organs/tissues recovered from this donor.Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination.There were no deviations from established procedures that may have increased the risk of contamination/cross contamination.All supplies and reagents used during the recovery were in compliance with (b)(4).The recovery was performed within the established time and temperature limits for recovery.Hcp reviews: after reviewing the chart and the processing report that revealed no nonconformities, our tissue was not the cause of the patients surgical complication.Furthermore, there is no evidence to suggest that an antibody response was the source of the complication.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.If information is provided in the future, a supplemental report will be issued.
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H10: medical safety assesses the reported event of ¿inflammatory reaction¿ and its reported severity as not related to the device because of the following: ¿ the review of gch records per the subject device part number batches did not identify any other events or complaints.The review of all details and records provided per the complaint record revealed no nonconformities nor any deviation to conclude that the medtronic devices were the cause of the patient¿s surgical complication or post-operative reaction.Collectively, based on the information provided, the medical review identified no evidence to suggest that an antibody response was the source of the complication.The event's immediate response (2 days) to the antibiotic treatment suggests infection as an alternative explanation.Infection is a common, inherent surgical risk associated with spine fusion surgery (parchi et al., 2015).Radiographic image assessment determine that post op mri for c4-c6 acdf, no dates are provided on the image but the left and right image appears to be from different time point.On the right sided tl sagittal image there is a hyper intense lesion at the c4-5 disc space which causes compression on the vertebral aspect of the spinal cord.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.
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Information was received from a health care facility via a manufacturer representative regarding a patient with congenital diaphragmatic hernia (cdh) for anterior cervical discectomy and fusion (alif) spinal therapy.It was reported that the it was an inflammatory reaction caused by the human origin of graft and patient did not achieve solid fusion because it was one month after the operation, the cage was replaced with a new one.The patient had temporary quadriplegia symptoms reported.Mri confirmed that inflammatory exudate appeared in the spinal canal.Quadriplegia occurred due to an inflammatory reaction occurred one month after the operation on (b)(6), but steroid and antibiotic disappeared for 2 days.Most likely inflammatory exudate.The physician said that it was antibody response of protein, etc.Of human origin.There were no further complications reported regarding the event.Additional information received states that the patient had headache, numbness in both hands a months before admission.The patient was introduced by a nearby doctor for weakness in both knees on (b)(6) 2020 and was admitted in our hospital on the same day.From (b)(6), the patient was having difficulty in walking and easy to fall, with appearance of skillful movement disorder, also using fork instead of chopsticks and having trouble with buttoning on his own.Mri showed spinal cord compression due to c4/5 herniation and a faint intramedullary t2 hyperintensity which led to steroid infusion.The patient was moved to neurosurgery on (b)(6) and had acdf on (b)(6).Post-op, the patient showed no fever, no signs of would infection, motor dysfunction improved, and the patient was discharged on (b)(6).The patient visited on (b)(6), upper limbs could be raised but had too little strength in left hand to lift a thing.Although being able to climb stairs and use chopsticks, numbness in both hands and weakness in left knee still present.Ten second test was negative, grip strength 31/18kg.X-ray image showed good positioning of the cage, subsidence very slight.The patient had been returning to work as a security guard, but weakness of his limbs abruptly appeared during night shift, transferred to the emergency room the following day on (b)(6).Mri showed increased exudate behind the cage, the post-op edema of the pharyngeal cavity had not been alleviated.Crp re-increased to 1.3 and diagnosed as inflammation and began steroids and antibacterial medication.Symptoms improved, surgery was performed on (b)(6) for identifying the cause and bacteria.Intra-op, no pus was found, the defective granulation dissected, and the cage replaced.Bacterial culture of the sample was negative.Histopathological examination con firmed xenobiotic reaction.Inflammation disappeared rapidly on image, and the patient was discharged and no recurrence found till the final visit to the hospital on (b)(6) 2021.The patient¿s inflammation was caused by the biological reaction to grafton.A 4 cm transverse incision along the wrinkles in the anterior neck.Confirmed the level through fluoroscope.Detached the longus coli muscle , but made a partial transverse incision at upper and lower ends to shorten the detachment length, then set retractor and incised all to reach intervertebral disc.Anterior bone was scarce.Disc was degenerated and easily removed.Drilling the posterior angle, incised the annulus fibrosis and pll to reach dura, hernia mass was found under the pll on left side, and removed it.Pll was removed and decomposed dural tube.Small amount of bleeding from the venous plexus, and performed hemostasis with apiten.Filled 6 mm cage with grafton, inserted it into vertebral body and checked fluoroscopy.Additionally filled grafton in left and right disc spaces and closed wound with a 3mm sb drain.Surgery time: 1hr 9 min; blood loss: slight.Platysma muscle that opened the previous incision was clearly observed without adhesion.Dissected and detached platysma muscle to proceed.Confirmed no adhesion but prevertebral fascia cloudy and thickened, so made incision after confirming level by fluoroscopy.Musculus longus colli was adhered to anterior surface of vertebral body, so placed retractor narrowly.Confirmed defective granulation-like status inside, no pus.Reached to disc cavity scraped defective granules in and around cage and used them for culture and tissue specimens.Went in with spreader, cage came off from position and removed it.Observed minute cage indentation on c5 endplate but bone was solid and seemed normal.In deep part on the dural side, found granuloma rich in blood vessels and had risk of bleeding sodissection was cancelled used abietin for hemostasis.After thorough cleaning, inserted 5 mm cage and loosed wound with 3mm sb drain.Exudate retention confirmed at implanted site.Tissue reaction possibly caused by the filling, but for the purpose of denying bacterial infection.Surgery time: 58 mins.The cage was removed due to suspicion of a xenobiotic reaction to the cage filling.Please make a tissue diagnosis of the filling.
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