MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/9MM; BONE PLATE

Model Number	04.503.061
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 is unknown.Date of event is unknown.Explant date is unknown.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 manufacture date is unknown.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 that patient was implanted with polyetheretherketone (peek) patient-specific implants (psi) as a bifrontal cranioplasty on an unknown date.After approximately one month, implants had to be removed due to infection.The hardware removal was successfully completed.Revision surgery will be scheduled to insert a new flap once patient heals from infection.Patient outcome was satisfactory.This is report 2 of 9 for (b)(4).

• Brand Name: TI MATRIXNEURO STRAIGHT PLATE 2 HOLES/9MM
• 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: 7673885
• Report Number: 2939274-2018-52769
• Device Sequence Number: 1554193
• Product Code: JEY
• UDI-Device Identifier: 10887587017938
• UDI-Public: (01)10887587017938
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K042365
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 05/04/2018

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: 04.503.061
• Device Catalogue Number: 04.503.061
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 07/10/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention