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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It was reported that the patient underwent a nc joint arthrodesis surgical procedure on (b)(6) 2019, utilizing paragon 28 baby gorilla/gorilla plating system.It was reported that the right template appeared chewed up, and was creating metal chards.This is report 1 of 2 for this incident.
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