MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; REFERENCE SENSOR

Model Number	403087
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the reference sensor.An investigation will be preformed once the reference sensor is returned from orthalign inc.'s distributor in (b)(4).With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result from an accuracy malfunction.A follow up report will be filed with the investigation findings.
Event or Problem Description
It was reported that total hip arthroplasty was performed with hipalign.Surgeon installed a cup to the patient hip with impactor connected to the reference sensor.However, angle of the cup was shown abnormally after the cup installation.Subsequently, conventional method was used to complete the procedure.
Additional Manufacturer Narrative
No fault could be found with the returned reference sensor, rs s/n: (b)(6).The reference sensor passed all visual and functional tests.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8759815
• Report Number: 3007521480-2019-00013
• Device Sequence Number: 2566289
• Product Code: OLO
• UDI-Device Identifier: 00858704006589
• UDI-Public: 00858704006589
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021

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 Model Number: 403087
• Device Catalogue Number: 403087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/05/2021
• 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