MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LOW PROFILE NEURO BURR HOLE COVER 15MM DIA; BONE PLATE

Model Number	421.526
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Hypoesthesia (2352); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
It was reported that on an unknown date, the patient underwent a microvascular decompression (mvd) procedure due to trigeminal neuralgia.The patient was implanted with burr hole cover and an unknown mesh plates.There was a surgical time of one-hundred forty-six (146) minutes.There were intra-operative complications.As the surgeon turned up towards the trigeminal nerve and then he encountered significant venous bleeding from a bridging vein proximal to the petrosal dandy vein.It was presumed that there must be a large petrosal vein bridging vein from the cerebellum to the petrosal sinus, but physician could not see it, and therefore it was packed that area with gelfoam.The surgeon had to wait several minutes for hemostasis and as the venous bleeding stopped, the procedure continued.The duration of follow up was of 1972 days.The healing status/radiographic outcomes at final follow-up was that the patient post procedure reported 100% relief to pain.It was also reported that patient had 50% numbness in the right tongue post mvd with sharp shooting pain in the right v2/v3 returned about nine (9) months ago.There were no post-operatives complication presented.The patient did not undergo reoperation.No further information is available.This report is for one (1) ti low profile neuro burr hole cover 15mm dia.This is report 1 of 3 for (b)(4).

• Brand Name: TI LOW PROFILE NEURO BURR HOLE COVER 15MM DIA
• Common Device Name: BONE PLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10426923
• Report Number: 2939274-2020-03660
• Device Sequence Number: 14166651
• Product Code: JEY
• UDI-Device Identifier: 10887587050584
• UDI-Public: (01)10887587050584
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K022012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 421.526
• Device Catalogue Number: 421.526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/19/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR