Catalog Number UNK_KIE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Post Operative Wound Infection (2446)
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Event Date 04/06/2021 |
Event Type
Injury
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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.
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Event Description
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The customer reported the following issue: "current patient status: post-operative infection requiring reoperation for removal of hardware, with risk of femoral fracture or extraction failure.Actions taken in the care facility to manage the patient: antibiotic therapy for 6 weeks.
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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.
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Event Description
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The customer reported the following issue: "current patient status: post-operative infection requiring reoperation for removal of hardware, with risk of femoral fracture or extraction failure.Actions taken in the care facility to manage the patient: antibiotic therapy for 6 weeks.
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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.The device inspection was not possible as the product was not returned for investigation.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.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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The customer reported the following issue: "current patient status: post-operative infection requiring reoperation for removal of hardware, with risk of femoral fracture or extraction failure.Actions taken in the care facility to manage the patient: antibiotic therapy for 6 weeks.
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Search Alerts/Recalls
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