MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS

Model Number	403001
Medical Device Problem Codes	Device Sensing Problem (2917); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The navigation unit displaying "sensor unstable" functioned as designed.The measurement of 141 mm is not within the expected range.The device has not been returned for evaluation.A review of the device history record yields no evidence of anomalies in the manufacture of this device.If the device is returned for evaluation a follow-up report will be filed.
Event or Problem Description
Orthalign navigation unit showed a system fault 6 during calibration, prior to patient use.When obtaining the cup angle the navigation unit screen displayed "system unstable" and would not display angles.When obtaining leg length the navigation unit displayed a measurement of 141 mm shorter at the end of the case.
Additional Manufacturer Narrative
Orthalign investigated the returned navigation unit.The events log from the navigation unit was downloaded and confirmed that the user experienced a system fault '6' (sensor test failure), and a fault 4 (key test failure) during the procedure.The system fault '6' failure explains the experience of the end user.A system fault '6' occurs during the power-up sequence of the navigation unit and indicates that the navigation unit's internal inertial measurement unit (imu) sensor exceeded the allowable operating ranges.This fault was reproduceable each time during the device's investigation.A fault of this nature indicates that the data relayed back to the navigation unit from the imu exceeds the allowable operational range, and as such the software safeguards against its usage by checking it during the power-up sequence.A faulty imu transmitting data outside of the allowable operational range can result in the system thinking that there is instability, and in general will provide inaccurate measurements/results during a procedure.It is suspected that the imu device's inoperable condition is a direct cause to the several issues encountered by the end-user.Orthalign has not been made aware of any injury to the patient nor any planned intervention as a result of this confirmed system fault.A review of the device history record yields no evidence of anomalies in the manufacture of this device.This report is being filed in an abundance of caution due to the potential risk of the system fault reporting inaccurate measurements.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: ORTHALIGN PLUS
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656 4107
• MDR Report Key: 7520582
• Report Number: 3007521480-2018-00001
• Device Sequence Number: 2011769
• Product Code: OLO
• UDI-Device Identifier: 00858704006534
• UDI-Public: 00858704006534
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 403001
• Device Catalogue Number: 403001
• Device Lot Number: 321036
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1