The information provided suggests the surgery was a lumbar interbody fusion performed without a cage and was mixed with allograft, all of which are not within the approved indicated labeling.If no interbody ring or cage was used, containment of the bone graft would likely be challenging, increasing the risk of migration.This is the 42nd report of migration (internal and external) for all i-factor product types.There have been approximately (b)(4) surgeries performed using i-factor products at the time of the event.Based on the current number of migration complaints the frequency of i-factor migration is ~(b)(4)%.Migration is a known potential risk of any bone graft material, including autograft.The current ifu package insert lists migration of the graft material as a potential adverse event, and there is also a statement of risk about the potential need for revision surgery.The dhr for lot 18c0493 indicates no discrepancies or deviations that may have contributed to the incident.There are no other similar complaints/incidents reported for this lot of product.Requested additional information from dr.(b)(6) via email on (b)(4) 2018.No response to email.No further information available.
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