MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC MATRIXNEURO MESH-PL 100*100 T0.6 CONTOUR; BONE PLATE

Model Number	04.503.121
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Reaction (2414)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient id, date of birth/age and weight were not provided for reporting.Date of event is unknown.Device remained implanted at the time of reporting.Device was not explanted.Device is not expected to be returned for manufacturer review/investigation.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 (b)(6) 2017, patient had a craniotomy.Patient was implanted with a titanium (ti) matrixneuro contour mesh, unknown quantity of ti matrixneuro screws, and non-synthes device noted as a suturable duragen.Postoperatively, on an unknown date, the patient developed a reaction to the implants, which the hospital nurse stated was hives.The patient remained in stable condition.There was no reported damage to any of these devices.Concomitant device reported: non-synthes suturable duragen device (part# unknown, lot# unknown, quantity 1).This report is for one (1) ti matrixneuro contour mesh 100mmx100mm/0.6mm rigid.This is report 1 of 2 for pc-000067311.

• 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: 7109474
• Report Number: 2939274-2017-50222
• Device Sequence Number: 1472097
• Product Code: JEY
• UDI-Device Identifier: 10887587018485
• UDI-Public: (01)10887587018485(10)LOT#UNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K042365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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: 04.503.121
• Device Catalogue Number: 04.503.121
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention