An mdr is indicated for this complaint.Patient was implanted with a prodisc l device at the l5/s1 level on (b)(6) 2023.Following the implantation surgery, the patient was found to have bilateral pars fractures at the index level.The patient is not experiencing any symptoms.The surgeon has determined that the patient will wear a brace and be re-evaluated in four months time.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined in the risk documentation.A review of the risk documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.There are no previous issues or capas associated with the complaint.The pdl device remains implanted within the patient, therefore no device evaluation could be completed.Bracing was needed for the bilateral pars fractures.A cause for the fractures is unknown, and no anomalies were identified during the course of the investigation.The submission is 3 of 3 devices involved in this event.
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