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U.S. Department of Health and Human Services

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

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ORTHALIGN INC. KNEEALIGN 2 REFERENCE SENSOR Back to Search Results
Model Number 133632
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2019
Event Type  malfunction  
Manufacturer Narrative
An orthalign distributor reported that the reference sensor used during a total knee arthroplasty had moisture inside and that is the believed cause of the reportable complaint regarding the system accuracy. The surgeon was looked for a flexion degree of 2 and the navigation unit read 18 degrees flexion after knee movements. This is outside of the fda cleared claim of +/- 3 degrees. Once the device is returned and investigated a follow up report will be filed. Orthalign is filing this initial mdr with extreme caution while considering the risk to the patient with a device being inaccurate and the potential harm that could cause.
 
Event Description
Sensor has moisture inside and orthalign plus unit read 18* flexion after knee movements.
 
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Brand NameKNEEALIGN 2
Type of DeviceREFERENCE 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
9202546370
MDR Report Key8610206
MDR Text Key146351352
Report Number3007521480-2019-00012
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163379
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 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number133632
Device Catalogue Number133632
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2018
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: 05/14/2019 Patient Sequence Number: 1
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