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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); No Code Available (3191)

Event Type  Injury  

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 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
• Type of Device: K042365
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10419728
• MDR Text Key: 203506682
• Report Number: 2939274-2020-03584
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10887587018102
• UDI-Public: (01)10887587018102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042365
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 04.503.081
• Device Catalogue Number: 04.503.081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR