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Patient height reported as 158cm.
Date of event is an unknown date in 2022.
Additional procode: ktt.
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.
Additional concomitant device: 2x unknown cable cerclage.
The investigation could not be completed; no conclusion could be drawn, as no product was received.
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 (b)(6) reports an event as follows: it was reported that during a meeting of the aotc held on (b)(6) 2021, slides were presented which represented four tfna cases with medial blade migration into the pelvic area.
All four cases were revised to a prosthesis.
This captures the case with patient: female, (b)(6) at time of event.
Patient began to complain of pain on (b)(6) 2022.
This report is for a tfna fenestrated helical blade 90mm - sterile.
This is report 1 of 1 for (b)(4).
Additional reports are captured under (b)(4).
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