SYNTHES USA TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
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Catalog Number 498.570 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Sedation (2368)
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Event Type
Injury
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Manufacturer Narrative
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This device was used for treatment, not diagnosis.(b)(4).(b)(6).Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient had initial surgery on (b)(6) 2016, operating on levels l3 to l5 with the cick'x system.After the initial surgery, the patient's pain continued to persist.On (b)(6) 2016, the surgeon decided to revise the implanted cick'x system by extending the construct.There was a 20-30 minute surgical delay and the patient's status is stable.(initial surgery in (b)(4)) this report is 6 of 18 for (b)(4).
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Search Alerts/Recalls
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