Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.B3: unknown when asd occurred.D9: complainant part is not expected to be returned for manufacturer review/investigation.D10 concomitant therapy date (b)(6), 2020.E1: initial reporter is j&j company representative.H4: device history; a review of the receiving inspection (ri) for single inner setscrew was conducted identifying that lot number 253228 was released in one batch.Batch1: lot qty of (b)(4) units were released on 22 aug 2019 with no discrepancies.Supplier : (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Device report from synthes reports an event in japan as follows: it was reported that this was an original unknown surgery occurred on (b)(6), 2020.Post-operatively on an unknown date, adjacent segment disease (asd) occurred.A revision surgery occurred to extend fixation and remove hardware on (b)(6), 2023.The sfx cross-link was removed.Set screw and rod were removed.Of the screws in l3-5, only l3 and l4 screws were removed.(bone fusion was completed) l5 screw were preserved.S additional screw of 7.0-45mm diameter was inserted.L5-s tlif was performed.(cage was other company¿s product.) sfx cross-link was placed, and the final tightening was done.This report is for one expedium spine system single inner set screw 5.5 for (b)(4).(b)(4) are linked.Additional impacted products are captured for the event.
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