Model Number MCP-50 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 09/14/2022 |
Event Type
Injury
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Event Description
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It was reported that a primary surgery for mcp arthritis took place on (b)(6) 2022.A couple of weeks later the finger got infected so an i&d and mcp implant swap out was performed.
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Manufacturer Narrative
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Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
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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.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.The dhr shows that the sterilization of this product was done according to specifications and that no deviation was found.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 that a primary surgery for mcp arthritis took place on (b)(6) 2022.A couple of weeks later the finger got infected so an i&d and mcp implant swap out was performed.
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Search Alerts/Recalls
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