Batch review performed on 16 january 2023.Lot: 2126491: (b)(4) items manufactured and released on 02-dec-2021.Expiration date: 2026-nov-16.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.Additional items involved in the event, batch review performed on 16 january 2023: pedicle screw 03.52.337 enh.Poly-axial pedicle screw - cannulated 7x40mm (k141988) lot: 2127340 lot: 2127340: (b)(4) items manufactured and released on 10-jan-2022.Expiration date: 2026-dec-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.
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Primary surgery performed 6 months ago (july 2022), l4-l5-s1 tlif.Six months later, l4-l5 presented bony fusion, however, l5-s1 resulted in pseudoarthrosis with s1 screw loosening.The cross-connector was located at l4-l5.At the revision surgery, the cross-connector was not stable already before removing the set screws.L4 and l5 pedicle screws were ok without any signs of loosening and l4-l5 was completely fused, but the cross-connector at l4-l5 showed loosening; while in l5-s1 was non-union and s1 screws were loose.
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Visual inspection performed on 20 february 2023 by medacta spine r&d project manager: the implant appears to be torsionally twisted.A new implant of the same reference has been taken off the shelf and has been twisted on purpose, using the countertorque.It was not possible to replicate the deformation of the implant object of the complaint, therefore a failure during implant insertion and final tightening has to be excluded.A certain root cause cannot be identified with the available information.
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