Surgery was performed at l4-l5.After inserting the mectalif oblique (ti peek) cage, when the surgeon was trying to adjust the position by using the final impactor (ref03.22.10.0263), he discovered that the thread of the cage was damaged.The remover could not be connected with the cage anymore.Competitor's instrument were used to remove the damaged cage and a new cage was implanted.Delay time 1 hour (total time of the surgery 5 hours).
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Batch review performed on 09 febr 2024 lot 1921457: (b)(4) items manufactured and released on 06-nov-2020.Expiration date: 2025-10-15.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.Preliminary analysis performed by r&d project manager according to the information received, the implant was inserted too ventral and so the surgeon tried to move it backward.At that time, he discovered that it was not possible to connect the cage with the remover because the posterior m4 thread was damaged.Because of that, he decided to remove the device and the cage was broken during the attempt.The posterior m4 thread was deformed probably due to the suboptimal mounting of the related inserter that caused a damage to the thread itself.The cages are checked both during the production and, after the coating, at 100% with an m4 go-nogo gauge.For these reasons, we can state that the deformation occurred after the unpackaging during the surgery.The root cause can be considered the suboptimal mounting of the related inserter on the implant.
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