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Device Problem
Expulsion (2933)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/04/2023 |
Event Type
Injury
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Manufacturer Narrative
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It was reported that a patient was implanted with a with a prodisc l implant at l5-s1, sometime in the summer of 2022.Approximately 6 months later, it was found that the poly inlay had slid anteriorly and the inlay was expulsed.A revision surgery was completed on (b)(6) 2023 to remove the old poly inlay and seat a new inlay within the pdl implant.A dhr review could not be completed as the part number and lot number were not provided and could not be determined from the information received as part of the investigation.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazard associated with this complaint is identified and mitigated to a level where the benefits outweigh the risks.Device evaluation could not be completed because although the poly inlay was returned it was very damaged from the removal process.It was confirmed that a revision took place due to poly inlay expulsion.No other anomalies associated with the complaint were found during the investigation.This report is for 3 of 3 devices involved in this event.
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Event Description
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Patient was implanted with a with a prodisc l implant at l5-s1, sometime in the summer of 2022.Approximately 6 months later, it was found that the poly inlay had slid anteriorly and the inlay was expulsed.A revision surgery was completed on (b)(6) 2023 to remove the old poly inlay and seat a new inlay within the pdl implant.
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Search Alerts/Recalls
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