The information provided by the reporter indicates and confirms an anterior migration of the pdc 6mm implant.The patient suffered an identical problem with a pdc 5mm implant and underwent revision on (b)(6) 2021 which was reported under mdr 3007494564-2021-00002.The replacement device migrated in an identical manner and required a second revision to a fusion.The patient reported no complications or symptoms as a result of either implant migration.There was no indication of comorbidities.The cause of the migration is unknown.The previous complaint indicated the patient fell leading to the migration.No traumatic event was indicated in this complaint.This complaint involves the same patient as 3007494564-2021-00002, but a difference device on a different day.Dhr review was completed without any noted problems in manufacturing.The risk assessment determined migration or loss of plate fixation is a known risk.The risk carries several possible harms though this complaint did not indicate a specific patient harm.The patient was revised to preclude possible harm.The explanted device was retrieved and shipped to exponent for scientific analysis.The device was assigned id: pdc-rd-0023.Analysis is currently in process.If there is evidence from analysis that would change the conclusions of this investigation, a follow up submission will be completed.The prodisc c us surgical technique guide and instructions for use were both reviewed.The review noted a precaution due to the unknown safety and effectiveness of prodisc c in patients with "prior surgery at the level to be treated".This may have been a factor in the migration since this patient was previously implanted with a pdc 5mm implant at the same level.
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