Device report from synthes reports an event in (b)(6) as follows: it was reported a screw fell apart post-operatively.The patient was diagnosed as "cervical spinal cord injury, cervical lumbar disc herniation and nerve root compression", and underwent the surgery, and implantation of screws on february 16, 2022.On the 54th day after operation, the x-ray showed that c3 and c5 screws were fell apart.It is unknown if a revision surgery took place.This is report 1 of 2 for (b)(4).This report is for an unknown spine screw.
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Event is post-operative; unknown event date.Brand name, common device name, manufacture name, city, and state, lot #, pma/510k: this report is for an unknown spine screw/unknown lot.Part and lot numbers are unknown; udi number is unknown.Concomitant medical products: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr and manufacture date: 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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