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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 403001-04
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2019
Event Type  malfunction  
Manufacturer Narrative
An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the navigation unit. While performing the cup implantation the accuracy of the navigation unit was off by 7 degrees. Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees. An investigation will be preformed once the unit is returned from orthalign inc. 's distributor in (b)(4). 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 7 degrees. A follow up report will be filed with the investigation findings.
 
Event Description
It was reported that a navigation unit prepared for total hip arthroplasty was performed with orhalign plus navigation. After cup installation, the unit display suddenly became black and the display went back to opening screen. Also, after preliminary cup fixation, the surgeon found actual angle showed in x-ray was different from the angle the navigation showed. (7 degrees) preliminary cup fixation: abduction 40 degree. X-ray photo: abduction 33 degree.
 
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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 Contact
katy nennig
120 columbia
suite 500
aliso viejo, CA 92656
9202546370
MDR Report Key8512163
MDR Text Key146351879
Report Number3007521480-2019-00009
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K172462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403001-04
Device Catalogue Number403001-04
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/26/2018
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: 04/13/2019 Patient Sequence Number: 1
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