The information provided indicates that the patient received a 2-level prodisc c implantation.At nearly 4 years post-op, the patient was scheduled for removal of both devices.The implants were positioned poorly and the posterior portion of the implants was in the spinal canal, the patient had also auto-fused.The removal was performed on (b)(6) 2022, and the pdc devices were replaced with fusion interbody cages.Synthes was the manufacturer of the implants, and the dhr has been requested from them to be reviewed.Complaint rates were found to be acceptable based on the analysis of the updated dfmea rates.The risk assessment determined the dmfea has identified the risks associated with this complaint.The devices were retained by the patient and no device evaluation could be completed.The investigation concluded that the positioning of the devices is likely the cause of the complaint and removal.This positioning is attributed to use error while implanting the device.This submission is 2 of 2 for this event.
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Patient was implanted with two prodisc c implants at level c 4/5 and c 5/6 by implanting surgeon on (b)(6) 2018.It was found that the implants were positioned poorly and that the posterior portion of the implants were in the spinal canal.The patient had also auto-fused.The removing surgeon, stated that there was no indication of a problem or a malfunction with the device itself, but rather that poor placement of the devices was a contributing factor.Patient was revised on (b)(6) 2022 and the pdcs were replaced with fusion interbody cages.
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