• 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. KNEEALIGN 2 SYSTEM REFERENCE SENSOR

  • 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. KNEEALIGN 2 SYSTEM REFERENCE SENSOR Back to Search Results
Model Number 133632
Device Problem No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2020
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. It cannot be determined how the reference sensor was assembled to the patient's tibia based on the contents of the event log, nor if this played any factor in the device output as reported by the user. The returned navigation unit and reference sensor were tested in-house. The two devices were tested by simulating a tka using saw-bones, performing a tibial and femoral navigations several times. All simulated usage passed, no issues were observed. The complaint cannot be confirmed based on the provided information. Orthalign, inc. Will continue to monitor this issue and take action when/if alert limits are exceeded.
 
Event Description
Inaccurate tibial alignment; the varus/valgus numbers displayed did not match actual alignment of the implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameKNEEALIGN 2 SYSTEM
Type of DeviceREFERENCE SENSOR
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
8665820879
MDR Report Key12302007
MDR Text Key265847605
Report Number3007521480-2021-00021
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103829
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 08/10/2021
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 Number133632
Device Catalogue Number133632
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 Received02/04/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-