Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, during an unknown procedure, the instrument was no longer able to hold the t-pal in a stable manner.No surgical delay reported.There was no adverse patient consequences.Another instrument was available, and the procedure was finished successfully.Concomitant device reported: unknown cage tpal (part# unknown, lot# unknown, quantity 1).This report is for one (1) t-pal spacer applicator knob.This is report 3 of 3 for (b)(4).
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