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U.S. Department of Health and Human Services

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

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ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT Back to Search Results
Model Number 403001-08
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Joint Laxity (4526)
Event Date 03/08/2022
Event Type  Injury  
Event Description
It was reported that the procedure was completed and components were submitted in place. The physician noticed a large gap in the lateral compartment of the knee. He had concerns that the unit may have maligned the femur, and wanted review of the device. The computer was taken off the field and it read, "navigation unit error, replace with new nav. Unit, return this unit. Stuck key 4. ".
 
Manufacturer Narrative
At this time the product has not been returned for investigation. 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 the patient could be subject to if the device produces inaccurate measurements.
 
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Brand NameORTHALIGN PLUS SYSTEM
Type of DeviceORTHALIGN PLUS NAVIGATION 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
MDR Report Key14042997
MDR Text Key288792095
Report Number3007521480-2022-00002
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number403001-08
Device Catalogue Number403001
Device Lot Number210811020LS
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2021
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: 04/07/2022 Patient Sequence Number: 1
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