Batch review performed on oct 11, 2018: lot 152328: (b)(4) items manufactured and released on 29 may 2015.Expiration date: 2020-04-22.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Additional implant listed in the complaint, as it cannot be defined which specific lot was the one involved: pedicle screw 03.50.031 pedicle screw 7x45, (k121115) lot 1820671: (b)(4) items manufactured and released on 7 august 2018.Expiration date: 24.07.2023-07-24.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Pedicle screw 03.50.030 pedicle screw 7x40, (k121115) lot 1820669: (b)(4) items manufactured and released on 25 february 2015.Expiration date:2023-08-19.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Pedicle screw 03.50.030 pedicle screw 7x40, (k121115) lot 1721547: (b)(4) items manufactured and released on 11 may 2018.Expiration date: 2023-03-13.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.Instrument involved in the failure of coupling and also broken during the same surgery: pedicle screw 03.51.10.0182 two-step reducer enhanced, lot 1755073: (b)(4) items manufactured and released on 26 march 2018.No anomalies found related to the problem.To date, no similar events have been reported on items of the same lot only the instrument was returned and the following visual inspection was performed the 11th of october 2018 by r&d project manager: three out of the four retaining pins (interface to the implant - pedicle screw head) are missing, due to failure of the welding.Only one pin was found during the surgery.It is possible that two pins were already missing before surgery, and that the device was already damaged from previous operations or due to wear and tear.In this case the instrument can still engage the implant but all the reduction force is supported by the two remaining pins which are therefore overstressed.The failure of the welding is in any case related to excessive reduction force applied and/or the forces (e.G.Lateral bending).The instrument set includes backup instruments.
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