Model Number UNKNOWN |
Device Problem
Expulsion (2933)
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Patient Problems
Pain (1994); Insufficient Information (4580)
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Event Date 04/22/2024 |
Event Type
Injury
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Manufacturer Narrative
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An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc l device in 2010 at l5-s1.It was found that the poly inlay had expulsed anteriorly.It was unknown if the patient is symptomatic.No revision has been scheduled at this time.A review of the dhrs could not be completed as the part numbers and lot numbers were not provided and could not be determined during the course of the investigation.Complaint trending found the rate of complaints to be within the levels outlined in the risk documentation.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.A device evaluation could not be completed as the device remains implanted within the patient.There were no anomalies identified during the investigation related to the complaint.The reason for the inlay expulsion is unknown.Submission is 3 of 3 devices involved in this event.
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Event Description
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A patient was implanted with a prodisc l device in 2010 at l5-s1.It was found that the poly inlay had expulsed anteriorly.It was unknown if the patient is symptomatic.No revision has been scheduled at this time.
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Manufacturer Narrative
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An mdr follow up report will be submitted for this complaint.It was reported that a patient was implanted with a prodisc l device at l5-s1 on (b)(6) 2014.Recently, the patient was experiencing new back pain with no known trauma or incident.It was found that the poly inlay had expulsed anteriorly.A surgeon removed the implant and replaced with a new pdl.Additionally, the disc at l4-5 was replaced with a new prodisc l device.A review of the dhrs could not be completed as the part number and lot number were not provided during the investigation and could not be determined.Complaint trending found that the rate of complaints is within the level outlined in the risk documentation.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The implant was retrieved and sent to exponent using a pdl retrieval kit.Exponent will complete device evaluation under pdl-rd-0013 using their standard pdl evaluation procedure.The reason for removal was due to the poly inlay expulsion, the cause of the inlay expulsion is unknown.This submission is 3 of 3 devices involved in this event.
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Event Description
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It was reported that a patient was implanted with a prodisc l device at l5-s1 on (b)(6) 2014.Recently, the patient was experiencing new back pain with no known trauma or incident.It was found that the poly inlay had expulsed anteriorly.A surgeon removed the implant and replaced with a new pdl.Additionally, the disc at l4-5 was replaced with a new prodisc l device.
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Search Alerts/Recalls
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