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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS UNIT; NAVIGATION UNIT
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ORTHALIGN, INC. ORTHALIGN PLUS UNIT; NAVIGATION UNIT Back to Search Results
Model Number 403001-05
Device Problem Incorrect Measurement (1383)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that when navigating the cup the version and abduction outputs were incorrect.The version of the cup and abduction were confirmed to be correct by the surgeon intraoperatively using c-arm.Once the product is returned, orthalign, inc.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 could be caused to the patient by an inaccurate device measurement.
 
Event Description
It was reported that when navigating the cup the version and abduction outputs were completely incorrect.The version of the cup and abduction were confirmed to be correct by the surgeon intraoperatively using c-arm.
 
Manufacturer Narrative
A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.
 
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Brand Name
ORTHALIGN PLUS UNIT
Type of Device
NAVIGATION UNIT
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo CA 92656
MDR Report Key10786293
MDR Text Key214590475
Report Number3007521480-2020-00013
Device Sequence Number1
Product Code OLO
UDI-Device Identifier00851977007901
UDI-Public00851977007901
Combination Product (y/n)N
PMA/PMN Number
K171780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number403001-05
Device Catalogue Number403001
Was Device Available for Evaluation? No
Date Manufacturer Received05/04/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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