MAUDE Adverse Event Report: WRIGHTS LANE: SYNTHES USA PRODUCTS LLC PSI SD800.427 PEEK IMPLANT; PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE

Model Number	SD800.427
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
Patient information is unknown.It is unknown when the event occurred.Complainant part has not been returned for manufacturer review/investigation.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 a patient who underwent surgery for repair of cranial defect on (b)(6) 2017 was admitted to the emergency room on (b)(6) 2018, with an infection and was subsequently revised that day.The peek psi implant and an unknown number of unknown plates and screws were removed to allow the active infection to heal; no additional implants were placed.The surgery was successfully completed with no intraoperative events or surgical delays.The patient will be revised once she has healed.The device is not available for investigation.This complaint involves three (3) devices.This report is for one (1) peek implant.This is report 1 of 3 for (b)(4).

• Brand Name: PSI SD800.427 PEEK IMPLANT
• Common Device Name: PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE
• Manufacturer (Section D): WRIGHTS LANE: SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7242230
• Report Number: 2939274-2018-50509
• Device Sequence Number: 1157888
• Product Code: GXN
• UDI-Device Identifier: 10887587065007
• UDI-Public: (01)10887587065007(10)MU17-ZAF-IKI
• Combination Product (Y/N): N
• Initial Reporter State: OR
• PMA/510(K) Number: K053199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2018

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: SD800.427
• Device Catalogue Number: SD800.427
• Device Lot Number: MU17-ZAF-IKI
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2018
• Initial Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention