Model Number P99-191-LT10 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Case information including related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
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Event Description
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It was reported that the patient underwent a surgical procedure that utilized paragon 28 phantom intramedullary nail system on (b)(6) 2019.The surgeon reported 3 lapidus nail drivers as defective.This is report 2 of 3 for this incident.
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Search Alerts/Recalls
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