Model Number PIP-20 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Insufficient Information (4580)
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Event Date 08/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.Device disposition is unknown.
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Event Description
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It was reported the doctor determined he did not remove enough osteophytes during the procedure.He replaced the device with a fresh one.
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Manufacturer Narrative
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Please note corrections to h6 (results and conclusion codes).The reported event could not be confirmed since the device was not returned for evaluation and no other evidence was provided.The event details clearly mention that the doctor determined he did not remove enough osteophytes during procedure which means there is no allegation about the product in itself.The change of the device was only precautionary.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If more information is provided, the case will be reassessed.
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Event Description
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It was reported the doctor determined he did not remove enough osteophytes during the procedure.He replaced the device with a fresh one.
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Search Alerts/Recalls
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