MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; REFERENCE SENSOR 2

Model Number 133632

Device Problem Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2021

Event Type  malfunction  

Manufacturer Narrative

No fault could be found with the returned reference sensor, rs2 s/n (b)(4).The rs passed all visual and functional tests.A review of the device history record (dhr) was conducted.There were no process deviations (pds) or nonconforming material reports (ncmrs) within the dhr.The device passed all manufacturing specifications prior to release.The root cause cannot be determined; no fault could be found with the returned part.Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.

Event Description

It was reported that the surgeon is claiming inaccurate readings on femur registrations for the reference sensor.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Type of Device: REFERENCE SENSOR 2
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656 ; 8665820879
• MDR Report Key: 12109456
• MDR Text Key: 259716783
• Report Number: 3007521480-2021-00018
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1