MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/RIGHT/2.5MM; BONE PLATE

Model Number	SD449.511B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.Device history lot: part number: sd449.511b; lot number: 3l20464; supplier lot number: n/a; manufacture date or release to warehouse date: 05/01/2019; expiration date: n/a; supplier/manufacture site: (b)(4).No ncrs were generated during production of lot number 3l20464.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Device history review: review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.
Event or Problem Description
It was reported that on an unknown date, the patient has had a cycle of infections since surgery.The boney flap calcified and properly unionized but there were issues of infection after the case.The plate has not been explanted and there was no plan to remove the implanted hardware.The surgeon mentioned that since it was an insistent problem and just wanted to confirm that there were no metals.Patient outcome is unknown.This complaint involves two (2) devices.This is report 1 of 2 for (b)(4).

• Brand Name: TI PSPC MATRIXMANDIBLE 7X23H ANGLE RECON PL/RIGHT/2.5MM
• 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: 9912254
• Report Number: 2939274-2020-01658
• Device Sequence Number: 16999987
• Product Code: JEY
• UDI-Device Identifier: 10887587004778
• UDI-Public: (01)10887587004778
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K063790
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: SD449.511B
• Device Catalogue Number: SD449.511B
• Device Lot Number: 3L20464
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 04/01/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention