Device was used for treatment, not diagnosis.This report is for an unknown device/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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.
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This is report 2 of 2 for (b)(4).It was reported that on (b)(6) 2021, a caller stated that she was implanted with a synthes tibia titanium plate and synthes titanium nail in 2017.It was reported that sometimes in 2021, she started experiencing electrical current going through her body from the implant site.It was reported that lately the symptoms persisted and were becoming unbearable.Caller visited her doctor but they could not find anything.The status of the patient was unknown.No additional information was provided.This report is for one (1) unk - plates: tibia device.This complaint involves two(2) devices.
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