Model Number UNK-P-TACTRA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Perforation (2001)
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Event Date 02/14/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient with this malleable device had a right proximal perforation which did not allow him to use the device.A revision surgery was performed to treat the perforation and replace the right side of the malleable device.No device issues nor additional patient complications were reported.
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Manufacturer Narrative
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use (ifu).Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient with this malleable device had a right proximal perforation which did not allow him to use the device.A revision surgery was performed to treat the perforation and replace the right side of the malleable device.No device issues nor additional patient complications were reported.
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Search Alerts/Recalls
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