MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER; PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE

Model Number	08.520.221S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device product code: ftl, ftm.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 (b)(6) 2019, the patient underwent removal procedure of synpor smooth titanium reinforced fan plate & titanium matrixmidface screw self-drilling due to infection.Originally the patient had an orbital floor fracture surgery on (b)(6) 2019.Implants were removed successfully.Patient outcome after the removal procedure is unknown.This report is for one (1) synpor smooth ti reinforced fan plate fixation.This is report 1 of 2 for complaint (b)(4).

• Brand Name: SYNPOR SMOOTH TI REINFORCED FAN PL FIXTN H/0.8MM THK-STER
• Common Device Name: PLATE, CRANIOPLASTY, PREFORMED, ALTERABLE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8803604
• Report Number: 2939274-2019-59255
• Device Sequence Number: 18912423
• Product Code: GWO
• UDI-Device Identifier: 10887587026428
• UDI-Public: (01)10887587026428
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2019

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: 08.520.221S
• Device Catalogue Number: 08.520.221S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention