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U.S. Department of Health and Human Services

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

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ORTHALIGN, INC. KNEEALIGN 2 SYSTEM REFERENCE SENSOR Back to Search Results
Model Number 133632
Device Problems Break (1069); Insufficient Information (3190)
Patient Problems No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
Event Date 11/11/2019
Event Type  Injury  
Manufacturer Narrative
A femur osteotomy was performed per angles provided by the kneealign 2 system as the sensor couldn't register the hip rotation accurately, resulted in valgus cut of the femur. At this time there is no known injury to the patient. Once the product is returned orthalign will perform an investigation into the alleged accuracy issue. Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that could be caused to the patient by an inaccurate device measurement.
 
Event Description
It was reported that the sensor couldn't register the hip rotation accurately. Resulted in valgus cut on the femur.
 
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Brand NameKNEEALIGN 2 SYSTEM
Type of DeviceREFERENCE SENSOR
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
Manufacturer (Section G)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
Manufacturer Contact
karyl haskel
120 columbia
suite 500
aliso viejo, ca 
MDR Report Key10186640
MDR Text Key201014115
Report Number3007521480-2020-00008
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K163379
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number133632
Device Catalogue Number133632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/18/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/03/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 06/23/2020 Patient Sequence Number: 1
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