Catalog Number 18220005S |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/20/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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It was reported that the end cap could not be inserted to complete the surgery.
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Event Description
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It was reported that the end cap could not be inserted to complete the surgery.
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Manufacturer Narrative
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Please note the correction to d9/h3.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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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.H3 other text : device disposition unknown.
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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 was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.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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Event Description
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It was reported that the end cap could not be inserted to complete the surgery.
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Search Alerts/Recalls
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