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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN INC. ORTHALIGN PLUS NAVIGATION UNIT

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ORTHALIGN INC. ORTHALIGN PLUS NAVIGATION UNIT Back to Search Results
Model Number 403001-04
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
Event Date 07/22/2019
Event Type  Injury  
Manufacturer Narrative
An orthalign distributor reported that a surgeon has noted that during a total knee arthroplasty found that the osteotomy that was performed using the orthalign plus navigation system was more valgus than expected. More information is needed to perform this investigation and as soon as all information is compiled orthalign will submit a follow up report. With an abundance of caution this report is being filed as orthalign understands the potential patient harm that could result from valgus osteotomy as navigated by the orthalign plus system. A follow up report will be filed with all investigation findings.
 
Event Description
It was reported that total knee arthroplasty was performed with kneealign. During femur registration, the surgeon adjusted flex 3 v/v 0 degree and then he proceeded the femur bone osteotomy. However, the surgeon found that the osteotomy was valgus more than he expected.
 
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Brand NameORTHALIGN PLUS
Type of DeviceNAVIGATION UNIT
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
9202546370
MDR Report Key8928289
MDR Text Key155489594
Report Number3007521480-2019-00019
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2020
Device Model Number403001-04
Device Catalogue Number403001-04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/18/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/14/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/23/2019 Patient Sequence Number: 1
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