Model Number 101-9810 |
Device Problem
Migration (4003)
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Patient Problems
Pain (1994); Discomfort (2330); No Code Available (3191)
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Event Date 11/19/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that the patient experienced discomfort and pain due to migration.X-ray imaging was performed that confirmed device migrated into a lateral displacement.The patient underwent an explant procedure wherein the implant was removed.The patient is doing well postoperatively.The device is in route to the manufacturer.
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Manufacturer Narrative
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Block h6 patient code: 3191: no code available, is used as there is no adequate fda code to describe a surgery.
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Event Description
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It was reported that the patient experienced discomfort and pain due to migration.X-ray imaging was performed that confirmed device migrated into a lateral displacement.The patient underwent an explant procedure wherein the implant was removed.The patient is doing well postoperatively.The device is in route to the manufacturer.
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Search Alerts/Recalls
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