MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO STRAIGHT PLATE 4 HOLES; BONE PLATE

Model Number	04.503.063
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); 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 an acoustic neuroma resection/craniotomy and surgery for wound washout and removal of hardware.The original implantation date was unknown.It is unknown if there was a surgical delay reported.The procedure outcomes were unknown.The patient was doing well after craniotomy/resection and then wound washout and removal of hardware.This complaint involves four (4) devices.This report is for (1) ti matrixneuro straight plate 4 holes.This is report 2 of 3 for (b)(4).

• Brand Name: TI MATRIXNEURO STRAIGHT PLATE 4 HOLES
• 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: 10408111
• Report Number: 2939274-2020-03534
• Device Sequence Number: 16782478
• Product Code: JEY
• UDI-Device Identifier: 10887587017952
• UDI-Public: (01)10887587017952
• 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): 07/24/2020

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: 04.503.063
• Device Catalogue Number: 04.503.063
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/14/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CRANIOS REINFORCED FAST SET PUTTY 5CC-STERILE; TI MATRIXNEURO ADAPTION PLATE 20 HOLES; UNK - SCREWS: MATRIXNEURO
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR