(b)(4).Customer has indicated that the product will not be returned to orthopediatrics for investigation as it is still implanted.The event was confirmed via communication with the surgeon, however item and lot numbers were never received.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Orthopediatrics will continue to monitor for trends.
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