Model Number 5572-4540 |
Device Problems
Material Invagination (1336); Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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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As reported: "implanted baseplate and when putting in peripheral screws the screw went through the baseplate.The metal casting that holds the screw was deformed.We had to take it out and put in a new one.Patient and outcome were fine." the baseplate and 6 screws were wasted.There are no allegations against the wasted screws.Surgery was completed successfully with a delay of approximately 1 hour.".
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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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Event Description
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As reported: "implanted baseplate and when putting in peripheral screws the screw went through the baseplate.The metal casting that holds the screw was deformed.We had to take it out and put in a new one.Patient and outcome were fine." the baseplate and 6 screws were wasted.There are no allegations against the wasted screws.Surgery was completed successfully with a delay of approximately 1 hour.".
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Search Alerts/Recalls
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