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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM REFERENCE SENSOR RS5H

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ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM REFERENCE SENSOR RS5H Back to Search Results
Model Number 403087-06
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
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. A review of the device history record (dhr) was conducted. The device passed all manufacturing specifications prior to release. No fault could be found with the returned reference sensor. Orthalign, inc. Will continue to monitor this issue and take action when/if alert limits are exceeded.
 
Event Description
While performing the acetabular navigation the surgeon;s cup reading was 22/13 after using xray validation he felt thathis numbers were closer to 40/13.
 
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Brand NameORTHALIGN PLUS SYSTEM
Type of DeviceREFERENCE SENSOR RS5H
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 Key12301633
MDR Text Key265851239
Report Number3007521480-2021-00020
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403087-06
Device Catalogue Number403087-06
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/16/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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