Device was used for treatment, not diagnosis.Report was initially submitted on (b)(6) 2016.Advised by fda on august 14, 2020 to resubmit medwatch.Patient initials are (b)(6).Patient weight reported as (b)(6) kg.A device history record review was performed for the subject device lot.The review revealed no complaint related anomalies.The device history record shows this lot of 8mmx22mm vertebral spacer¿pr was processed through the normal manufacturing and inspection operations with no non-conformances or rework noted.This order met all dimensional and visual criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record revealed this lot met all specifications at time of acceptance.No nonconforming reports were noted.The raw material met all dimensional and visual criteria at the time of release with no issues documented.The subject device has been received and is currently in the evaluation process.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 is reported during a posterior lumbar fusion procedure at l3-l4 and l4-l5, while surgeon was impacting the peek implant (vertebral spacer-pr) at l3-l4, the device shattered into approximately six (6) pieces.All the pieces were easily retrieved.Another peek implant was readily available and was used to complete the procedure successfully with no further harm to patient.The procedure was delayed approximately five (5) minutes due to this event.The patient reported to be doing well post-operatively.This is report 1 of 1 for (b)(4).
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