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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN ORTHALIGN PLUS NAVIGATION UNIT

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ORTHALIGN ORTHALIGN PLUS NAVIGATION UNIT Back to Search Results
Model Number 403001
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); No Apparent Adverse Event (3189)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2019
Event Type  malfunction  
Manufacturer Narrative
A customer experience report was submitted to orthalign from a regional sales manager stating that a navigation unit was showing inaccurate leg length information to the surgeon. The procedures were believe to have been properly executed. Orthalign fully expects to receive the navigation unit in question to investigate. At this point in time there is no information available to come to a conclusion as to what may have caused this inaccuracy. Orthalign is filing this medical device report with abundance of caution with the knowledge of how an inaccurate leg length reading has the potential to result in patient injury. When results of the investigation regarding the device in question is complete a follow up report will be filed.
 
Event Description
(b)(4). The unit was giving very inaccurate leg length. All procedures were believed to have been properly executed.
 
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Brand NameORTHALIGN PLUS
Type of DeviceNAVIGATION UNIT
Manufacturer (Section D)
ORTHALIGN
120 columbi
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 Key8946198
MDR Text Key194314483
Report Number3007521480-2019-00020
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172462
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 06/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model Number403001
Device Catalogue Number403001-05
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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