Model Number MCP-20 |
Device Problems
Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
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Patient Problem
Insufficient Information (4580)
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Event Date 04/11/2022 |
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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It was reported that the initial implanted device was too small and dislocated.Surgeon implanted a larger implant.
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Event Description
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It was reported that the initial implanted device was too small and dislocated.Surgeon implanted a larger implant.
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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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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Search Alerts/Recalls
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