Batch review performed on 19-apr-2023; lot 2121497: (b)(4) items manufactured and released on 23-jul-2021.Expiration date: 2026-07-07.No anomalies found related to the problem.To date, 51 items of the same lot have been sold with no similar reported case during the period of the review.Clinical evaluation performed by medical affairs director: one year after thoraco-lumbar fusion on 4 levels one of the rods broke and needed exchanging.We have no history of the case and the one picture supplied is of extremely low quality, so that it's impossible to offer a thorough reconstruction of the case.It can be assumed that it originated from a vertebral fracture which did not heal completely after one year.In these conditions, the temporary implants are subject to fatigue failure.In this case, the necessity of bridging the broken vertebra exposed the rod to an increased stress and, coupled with the lack of fusion at 12 months, fracture occurred.Visual inspection performed by r&d manager: as can be seen in the x-ray and in picture sent, the rod broke.The construct is made of 4 screws that cover 5 vertebrae, with the central vertebra without screw.The cracking happened adjacent to the two upper pedicle screws, on the side facing the not supported area.It is unknown if any traumathic event that may have reduced the strength of the implant occurred.The root cause may have been a lack bone fusion combined with the missing support of a screw in the level adjacent to the breakage plane.
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