MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXMIDFACE SCREW SELF-TAPPING 3MM; BONE PLATE

Model Number	04.503.203.01
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
Additional device product code: dzl.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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 a removal of cranios reinforced fast set putty, one (1)titanium matrixneuro reconstruction mesh, one (1) 3mm titanium matrix midface screw, one (1) 10mm titanium matrix midface screw, and one (1) 4mm titanium matrix midface screw due to c difficile infection postoperatively.Original date of surgery was on (b)(6) 2015.The patient was on a cephalexin antibiotic therapy due to complication known on (b)(6) 2015.It is unknown if there was surgical delay.Procedure and patient outcome was unknown.This report is for one (1) ti matrixmidface screw self-tapping 3mm.This is report 3 of 5 for (b)(4).

• Brand Name: TI MATRIXMIDFACE SCREW SELF-TAPPING 3MM
• 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: 9587494
• Report Number: 2939274-2020-00179
• Device Sequence Number: 3389033
• Product Code: JEY
• UDI-Device Identifier: 10887587018720
• UDI-Public: (01)10887587018720
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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: 04.503.203.01
• Device Catalogue Number: 04.503.203.01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 18 YR