|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Pain (1994); Hypoesthesia (2352); No Code Available (3191)
|
Event Type
Injury
|
Manufacturer Narrative
|
This report is for an unknown plates: cmf/ unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.(b)(4).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.
|
|
Event Description
|
It was reported that on an unknown date, the patient underwent a microvascular decompression procedure due to trigeminal neuralgia.Patient was implanted with an unknown mesh plates and burr hole cover.There was a surgical time of one-hundred thirty-five (135) minutes.There was no intra-operative complication.The healing status and radiographic outcome at the final follow-up was that the surgery helped for about one year, but pain has recurred.Three (3) weeks ago, the patient had a severe recurrence, and required medications, and had mild numbness of the face in the v2/v3 region at 80%.There was no post-operative complication presented.The patient did not undergo re-operation.The patient outcome is unknown.No further information is available.This report is for one (1) unk - plates: cmf.This is report 2 of 3 for (b)(4).
|
|
Search Alerts/Recalls
|
|
|