Devices are not expected to be returned for the manufacturer review/investigation.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 surgical procedure that utilized paragon 28 gorilla plating system.The surgeon reported that the r3con locking screw was sitting proud in the distal hole of the 5 hole t plate.It was reported that the surgeon bent the plate at the compression slot, and the non-locking screw sat flush with the plate.The drill locking towers was used for the pre-drill holes.The initial reporter mentioned that the holes were drilled bi-cortical.Patient information was not reported, and a revision surgery was not stated.
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