Catalog Number QS8918 |
Device Problems
Break (1069); Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/19/2023 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
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Event Description
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According to the available information the patient believes the implant is leaking due to a break in the tubing.
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Event Description
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According to the available information the device was explanted due to a break in the tubing.
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.
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Event Description
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According to the available information the device was explanted and replaced due to a break in the tubing.
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release.No trends were noted for complaints and there were no nonconforming reports or capas that were confirmed to be associated.Date of event is an estimated date.
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Search Alerts/Recalls
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