Additional product code: kwp; kwq; mnh; mni; osh.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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.
|
Device report from synthes reports an event in (b)(6) as follows: it was reported on (b)(6) 2020 a removal procedure was performed.It was found that the setscrew (199721001s), which was implanted on the tail side, had become loose.Concomitant device reported: exp verse unitized set scr (part # 199725855s, lot # unknown, quantity # 1), unknown screws (part # unknown, lot # unknown, quantity # 1).This complaint involves one (1) device.This is report 1 of 1 for (b)(4).
|