MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO BOX PLATE 10MM X 16MM; BONE PLATE

Model Number	04.503.073
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
Patient information not available for reporting.Date patient infection began is not known.Date of implant is not known.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.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 patient was implanted with one (1) patient specific implant (psi) polyetheretherketone (peek) implant, fifteen (15) matrixneuro screws, and four (4) matrixneuro box plates on unknown date.On unknown date it was determined patient had developed an infection at the implant site.Patient was returned to surgery on (b)(6) 2018 where all hardware was removed.It is not known if additional hardware was implanted.No further information was provided.Due to system limitations, the psi peek implant and nine (9) of the screws are addressed in (b)(4).This report will address the remaining devices.This report is for one (1) matrixneuro box plate.This is report 7 of 10 for (b)(4).

• Brand Name: TI MATRIXNEURO BOX PLATE 10MM X 16MM
• 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: 7846916
• Report Number: 2939274-2018-53618
• Device Sequence Number: 19216215
• Product Code: JEY
• UDI-Device Identifier: 10887587018058
• UDI-Public: (01)10887587018058
• 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
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/09/2018

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: 04.503.073
• Device Catalogue Number: 04.503.073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/05/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention