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U.S. Department of Health and Human Services

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

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ORTHALIGN INC. ORTHALIGN PLUS NAVIGATION UNIT Back to Search Results
Model Number 403001-05
Device Problems Incorrect Measurement (1383); 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 second navigation unit that the surgeon attempted to use gave a flexion reading of 11 degrees. This was again an extreme angle that the surgeon knew was incorrect. Orthalign's representative noted that this particular surgeon has done hundres of cases and know this. Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees. This navigation unit was discarded after use. An investigation into the dhr for this device will be preformed and a follow up report will generated and submitted. With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result from an accuracy malfunction of this magnitude. A follow up report will be filed with the investigation findings.
 
Event Description
Navigation unit ((b)(4)) gave a flexion reading of 11 degrees, extreme.
 
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Brand NameORTHALIGN PLUS
Type of DeviceNAVIGATION 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
9202546370
MDR Report Key8584229
MDR Text Key146352215
Report Number3007521480-2019-00011
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 company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model Number403001-05
Device Catalogue Number403001-05
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/07/2019
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: 05/06/2019 Patient Sequence Number: 1
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