Product complaint # (b)(4).Without a valid lot number the device history records review could not be completed.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable 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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It was reported that on (b)(6) 2021, during spinal fusion surgery the surgeon was revising an l1 to s1 construct.The patient previously had a 3 level alif (competitor products) and it was backed up by an l1/s1 construct using expedium 5.5 ti.The anterior cages did not fusing which caused a non-union.The surgeon was revising the posterior construct from t11 to l1 using expedium 5.5 ti and viper fenestrated.Surgeon was using viper fenestrated screws and confidence cement.At s1.The surgeon pumped cement through the screw at the left side of s1 and some of the cement leaked anteriorly of the s1 vertebral body.There was a surgical delay of five to ten (5 to 10) minutes.There were fragments generated.Patient status is unknown.The procedure was successfully completed.This complaint involves two (2) devices.This report is for (1) confidence kit, no needles this report is 2 of 2 for (b)(4).
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