• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS NAVIGATION UNIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ORTHALIGN, INC. ORTHALIGN PLUS NAVIGATION UNIT Back to Search Results
Model Number 403001-05
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problems No Known Impact Or Consequence To Patient (2692); Joint Laxity (4526)
Event Date 07/09/2020
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 greater than 3 degrees. Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees. An investigation will be performed once the unit is returned from orthalign inc. 's distributor in (b)(6). 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 greater than 3 degrees. A follow up report will be filed with the investigation findings.
 
Event Description
It was reported that total hip arthroplasty was performed with hipalign, supine approach. The surgeon planned that target cup angle was 40/15 degrees. The procedure was proceeded in accordance with the target cup angle. After cup impaction, the navigation showed that the cup was installed with 39/14 degrees (cup angle). Postoperatively, he confirmed x-ray photos of the cup angle and abduction angle of the cup was 56 degrees.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameORTHALIGN PLUS
Type of DeviceNAVIGATION UNIT
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
Manufacturer (Section G)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo, ca
Manufacturer Contact
karyl haskel
120 columbia
suite 500
aliso viejo, ca 
MDR Report Key10394279
MDR Text Key203147844
Report Number3007521480-2020-00011
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K171780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number403001-05
Device Catalogue Number403001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-