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	08/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We reviewed the issue and initial procedure with the surgeon.No device defects or malfunctions were detected.No fracture or other complications were observed during the initial procedure.The orthalign plus device performed normally during the procedure.X-rays were not provided to orthalign.It is unclear where the fracture originated in the tibia.It is unclear what specifically caused the fracture.
Event or Problem Description
A surgeon reported that a patient who had undergone an unicompartmental knee arthroplasty procedure navigated by the orthalign plus system returned three and a half months later with a fracture in the tibia below the tibial resection.The fracture required a revision procedure with a long tibial stem to constrain the arthroplasty components and bypass the fracture 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: 7011820
• Report Number: 3007521480-2017-00005
• Device Sequence Number: 497662
• 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: 10/26/2017
• 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: 54 YR
• Patient Weight: 84