Information was received from the healthcare professional (hcp) via manufacturer representative regarding an event that occurred during a spinal fusion procedure for a patient diagnosed with degenerative kyphoscoliosis.It was reported that the rod broke during use.A re-operation was performed on (b)(6) 2020 to explant the rod, and its fragments.The reason for breaking of rod, as the bone fusion was achieved, was unknown.In reoperation the broken rod was replaced, and by mrc the rod was added inside, re-fusion was performed with 4 rods.The removed rod was discarded by medical instrument, it will not be returned.
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