Batch review performed on 17 march 2023: lot 2125448: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-oct-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.Clinical evaluation performed by medical affairs department: a few days after primary lumbar posterior stabilization surgery, the surgeon finds that two pedicle screws are in fact outside of the vertebral body.We do not know if this situation was already present right after surgery or if it was an evolutionary status.In the former case, we have no information as to why no action was taken during primary surgery.In the latter case, we have no viable hypothesis to offer as to the mechanics of such unfavorable evolution.We can hardly imagine that this is due to a defective device.Mysolution planning review: our analysis of the myspine process in this case found no deviations from the standard procedures.Each step has been performed correctly.We reprinted the guides l02 and l03 and confirmed that the fitting is stable and univocal.Other device involved: pedicle screw 03.52.314 enh.Poly-axial pedicle screw - cannulated 5x40mm (k141988) lot 2125448: (b)(4) items manufactured and released on 15-nov-2021.Expiration date: 2026-oct-28.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported event during the period of review.
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