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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
Medical Device Problem Code Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
At this time the product has not been returned for investigation.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.
 
Event or Problem Description
It was reported that the summary screen flexion extension numbers did not match the previous originally registered flexion extension numbers.
 
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Brand Name
ORTHALIGN PLUS SYSTEM
Common Device Name
ORTHALIGN PLUS NAVIGATION UNIT
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo CA 92656
MDR Report Key12719478
Report Number3007521480-2021-00025
Device Sequence Number3984305
Product Code OLO
UDI-Device Identifier00858704006534
UDI-Public00858704006534
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K162962
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number403001
Device Catalogue Number403001
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/28/2021
Initial Report FDA Received Date10/29/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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