MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.7MM THICK; BONE PLATE

Model Number	04.503.376
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Weakness (2145)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional code: dzl.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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 an acoustic neuroma resection retrosigmoid procedure.Patient was implanted with an unknown bone plates and putty cement.Postoperatively, the patient's surgery was complicated by swelling of the neck which required the patient to be kept intubated for an extra two days for airway protection.The patient's shoulder was mildly weak after the surgery and was attributed to brachial plexus stretch injury.The patient is making good progress and the post operative complications were resolved.Patient's outcome is unknown.This is report 2 of 3 for (b)(4).

• Brand Name: TI MATRIXMIDFACE ADAPTION PLATE/20 HOLES/0.7MM THICK
• 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: 10420805
• Report Number: 2939274-2020-03601
• Device Sequence Number: 14219466
• Product Code: JEY
• UDI-Device Identifier: 10887587020198
• UDI-Public: (01)10887587020198
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K083388
• 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): 08/04/2020

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: 04.503.376
• Device Catalogue Number: 04.503.376
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIOS REINFORCED FAST SET PUTTY 3CC-S; UNK - SCREWS: MATRIXMIDFACE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR