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U.S. Department of Health and Human Services

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

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ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM ORTHALIGN PLUS NAVIGATION UNIT Back to Search Results
Model Number 403001-05
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem Joint Laxity (4526)
Event Date 07/06/2020
Event Type  Injury  
Manufacturer Narrative
An investigation of returned navigation unit log file found the femoral axis registration numbers were beyond typical numbers. The user received the jig out of range error several times until the jig was re-pinned. The numbers indicate the jig was likely pinned too high or incorrectly, this is further supported by the fact the user selected an a/p offset of 1 which is the minimum amount. If the true a/p offset was a higher number, the output would have been closer to a nominal case. Root cause was unable to be determined for this complaint but since the behavior described is shown in the log file, the complaint can be confirmed. 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. 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.
 
Event Description
It was reported that after femoral registration the unit read 24 degrees of flexion. Femoral pin was reinserted and range of motion was redone. Unit read 15 degrees of flexion and the surgeon was able to adjust the cutting block until the unit read 5 degrees of extension. After cut was made the surgeon noticed that the cut "didnt look right" an im guide was used to redo the cut. Item worked normally on the tibia and the case was completed with no other issues. The femoral registration was started with the leg in flexion. This was the only position the allowed the unit to show the green box.
 
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Brand NameORTHALIGN PLUS SYSTEM
Type of DeviceORTHALIGN PLUS NAVIGATION UNIT
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
MDR Report Key12099233
MDR Text Key259391423
Report Number3007521480-2021-00015
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K172462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number403001-05
Device Catalogue Number403001
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/01/2021 Patient Sequence Number: 1
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