STRYKER GMBH SILICONE II MCP IMPLANT SIZE 50 (STERILE PACKED); PROSTHESIS, FINGER, CONSTRAINED, POLYMER
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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 11/29/2022 |
Event Type
Injury
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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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Event Description
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As reported: "the patient presented with infection, cause unknown.Replaced implant with identical implant.".
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Event Description
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As reported: "the patient presented with infection, cause unknown.Replaced implant with identical implant.".
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Manufacturer Narrative
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The reported event could not be confirmed, since the device, was not returned and no additional information was available.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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