MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO CONTOUR MESH 38MM X 45MM/0.4MM MALLEABLE; K042365

Model Number	04.503.081
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.(b)(4).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 procedure due to trigeminal neuralgia.The patient was implanted with titanium matrixneuro contourable mesh plates and cranios reinforced fast set putty cement.There was a surgical time of 118 minutes.There was no intraoperative complication.The healing status and radiographic outcome at the final follow-up was that the patient reports 100% relief, very much improved, and the patient is off all drugs.There was no postoperative complication presented.The patient undergoes right sided cranioplasty and revision because of persistent occipital headaches, left microvascular decompression.The patient outcome is unknown.This complaint involves an unknown number of devices.This report is for (1) ti matrixneuro contour mesh 38mm x 45mm/0.4mm malleable.This is report 1 of 2 for (b)(4).

• Brand Name: TI MATRIXNEURO CONTOUR MESH 38MM X 45MM/0.4MM MALLEABLE
• Common Device Name: K042365
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10419728
• Report Number: 2939274-2020-03584
• Device Sequence Number: 11511047
• Product Code: JEY
• UDI-Device Identifier: 10887587018102
• UDI-Public: (01)10887587018102
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: study
• 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: 04.503.081
• Device Catalogue Number: 04.503.081
• 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: 08/18/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR