Visual inspection performed by medacta spine r&d project manager: the two pedicle screw ref.03.50.030, lot 155082, are broken approximately 10mm below the pedicle screw head.All the other explanted implant are without any damaging.The root cause of the event is unknown, probably is due to a huge load on the lower pedicle screw implanted in s1.Despite of the breakage as reported in the tf: vi-ps-01 the implant, in worst case configuration, can accomplish the requirements of the standard and it's comparable or better refer to the implants already on the market.
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