MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.8MM THICK; PLATE, BONE

Model Number	04.503.396
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an acoustic neuroma resection retrosigmoid procedure.Patient was implanted with unknown bone plates and putty cement.Immediately after the surgery, the patient experienced severe facial paralysis.The patient had right masseter nerve to facial nerve transfer, and temporalis tendon transfer.The complication was resolved.The patient outcome is unknown.No further information is available.This report is for 1 ti matrixmid face adaption plate/20 holes/0.8mm thick.This is report 2 of 3 for (b)(4).

• Brand Name: TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.8MM THICK
• Common Device Name: PLATE, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10391517
• Report Number: 2939274-2020-03465
• Device Sequence Number: 1875130
• Product Code: JEY
• UDI-Device Identifier: 10887587020396
• UDI-Public: (01)10887587020396
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 04.503.396
• Device Catalogue Number: 04.503.396
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIOS RNFRCD FAST SET PUTTY 3CC-ST; UNK - SCREWS: MATRIXMIDFACE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR