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U.S. Department of Health and Human Services

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

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ORTHALIGN, INC. ORTHALIGN PLUS REFERENCE SENSOR Back to Search Results
Model Number 403087
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/27/2019
Event Type  malfunction  
Manufacturer Narrative
An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the reference sensor. An investigation will be preformed once the reference sensor 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. A follow up report will be filed with the investigation findings.
 
Event Description
It was reported that total hip arthroplasty was performed with hipalign. Surgeon installed a cup to the patient hip with impactor connected to the reference sensor. However, angle of the cup was shown abnormally after the cup installation. Subsequently, conventional method was used to complete the procedure.
 
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Brand NameORTHALIGN PLUS
Type of DeviceREFERENCE SENSOR
Manufacturer (Section D)
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 Key8759815
MDR Text Key190384091
Report Number3007521480-2019-00013
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 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403087
Device Catalogue Number403087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2018
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: 07/03/2019 Patient Sequence Number: 1
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