It was reported that a patient was implanted with a prodisc l device at l4-5 on (b)(6) 2021.Patient was completely asymptomatic until 2-3 months ago.Presented with new complaints of lower back pain, adjacent level pathology was ruled out.It was found that the inlay was expelled.Surgeon was treating conservatively and no additional treatment has been scheduled.It was determined that the complaint was an mdr reportable due to device malfunction.Three devices were involved in the complaint, the prodisc l superior plate, the poly inlay, and the inferior plate.For the inferior plate, dhr was not available to review.Complaint trending found that the rate of complaints to be within the poc indicated in the risk assessment.A review of the risk assessment found that the risks are identified and mitigated to a level where the benefits outweigh the risk.Device evaluation could not be completed as the pdl device remains implanted within the patient.This report is for 2 of 3 devices involved in this event.
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It was reported that the prodisc l poly inlay had "popped out" and unlocked from the inferior endplate, premature poly wear, expulsion.Patient was implanted with a prodisc l device at l4-5 on (b)(6) 2021.Patient was completely asymptomatic until 2-3 months ago.Presented with new complaints of lower back pain, adjacent level pathology was ruled out.It was found that the inlay was expelled.Surgeon was treating conservatively and no additional treatment has been scheduled.
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