Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes.Hcps reviews based on donor charts: medical director reviewed the donor chart, and the tro answers to the relevant questions, and he believe that the complaint is unrelated to tissues as received, processed, stored and distributed by medtronic.In compliance with fda guidance on investigation of adverse reactions related to hct/ps, can you please confirm the following for this donor: any additional reports of adverse reactions involving any other organs/tissues recovered from this donor; none.Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination; yes.There were no deviations from established procedures that may have increased the risk of contamination/cross contamination; no deviations from procedures.All supplies and reagents used during the recovery were in compliance with 21cfr1271.210; yes.The recovery was performed within the established time and temperature limits for recovery.Yes.If information is provided in the future, a supplemental report will be issued.
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The information was received from health care provider via a manufacturing representative regarding a patient with spinal stenosis f or posterolateral 2 level lumbar tlif spinal fusion therapy.It was reported that patient had a bad inflammatory response at the site of the graft.Patient had back pain, doctor admitted patient to hospital and removed all the graft.The revision surgery was conducted on (b)(6) 2021.There was no infection suspected, present, or treated.The patient didn't achieve solid fusion.There was no further information reported.
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