MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; COMPUTER ASSISTED SURGERY SYSTEM

Model Number	403001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/12/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We reviewed the issue and procedure with the surgeon.No device defects or malfunctions were detected.The orthalign plus device performed normally during the procedure.X-rays were not provided to orthalign.The fracture apparently happened while placing the mounting pins for the cutting block.
Event or Problem Description
A surgeon reported that a fracture in the tibia occurred during placement of the tibial cutting block during an unicompartmental knee arthroplasty procedure navigated by the orthalign plus system.The fracture required use of a small fragment plate and screws to stabilize the proximal tibia below the resection site.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: COMPUTER ASSISTED SURGERY SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia, suite 500; aliso viejo CA 92656
• MDR Report Key: 7012102
• Report Number: 3007521480-2017-00006
• Device Sequence Number: 518671
• Product Code: OLO
• UDI-Device Identifier: 00858704006534
• UDI-Public: 00858704006534
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K171780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2017

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: 403001
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/08/2017
• 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: Other
• Patient Age: 35 YR
• Patient Weight: 64