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

Model Number 133632

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Laxity (4526)

Event Date 07/03/2019

Event Type  Injury  

Manufacturer Narrative

The returned reference sensor was functionally tested using an in-house navigation unit.The reference sensor successfully performed simulated procedures by performing back table calibration and simulated procedures using saw bones.The reference sensor was found to function as designed.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.This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.

Event Description

Surgeon feedback that the knee cut was valgus after checking x ray (post-op).

• Brand Name: KNEEALIGN 2
• Type of Device: REFERENCE SENSOR
• 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
• MDR Report Key: 12097327
• MDR Text Key: 259362351
• Report Number: 3007521480-2021-00012
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K163379
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2018
• 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
• Patient Outcome(s): Required Intervention