This device was used for treatment, not diagnosis.Date of event: unknown.Additional code: mni, mnh, kwp, kwq.(b)(4) unknown lot number.(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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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 14 of 18 for (b)(4).
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