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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 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).
 
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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
MDR Report Key12097326
MDR Text Key259362221
Report Number3007521480-2021-00011
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00858704006015
UDI-Public00858704006015
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
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 Received06/30/2021
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 Manufacturer11/07/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2018
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: 06/30/2021 Patient Sequence Number: 1
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