Catalog Number DWX3SS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Implant Pain (4561)
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Event Date 01/05/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient has complex regional pain syndrome.Patient started experiencing symptoms 2 weeks post operatively.Patient has been going to physio therapy to manage symptoms.Event is ongoing.
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
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Event Description
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It was reported that the patient has complex regional pain syndrome.Patient started experiencing symptoms 2 weeks post operatively.Patient has been going to physio therapy to manage symptoms.Event is ongoing.
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Manufacturer Narrative
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The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing & design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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Search Alerts/Recalls
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