Batch review performed on 11-nov-2022: lot 2222997: (b)(4) items manufactured and released on 13-jul-2022.Expiration date: 2027-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Additional component involved: batch review performed on 11-nov-2022: must lt 03.57.035 must lt 15mm short - pedicle screw ø7x45 cann (k203482) lot 2222427: (b)(4) items manufactured and released on 07-jul-2022.Expiration date: 2027-06-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Must lt 03.57.035 must lt 15mm short - pedicle screw ø7x45 cann (k203482) lot 2220332: (b)(4) items manufactured and released on 20-apr-2022.Expiration date: 2027-02-20.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.Must lt 03.57.035 must lt 15mm short - pedicle screw ø7x45 cann (k203482) lot 2221910: (b)(4) items manufactured and released on 19-may-2022.Expiration date: 2027-05-02.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been sold with no similar reported case during the period of review.
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At about 1 month after the primary surgery, a revision surgery was performed because 4 of the 6 reported screws backed out.Moreover, during the revision a screw was replaced with new one but it was loosened during rod fixation.The screw was replaced again and a complaint was opened.The surgery was anyway completed successfully without critical delay.
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