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U.S. Department of Health and Human Services

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

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ORTHALIGN, INC. ORTHALIGN PLUS UNIT NAVIGATION UNIT Back to Search Results
Model Number 403001-08
Device Problem Incorrect Measurement (1383)
Patient Problem Joint Laxity (4526)
Event Date 05/26/2022
Event Type  Injury  
Manufacturer Narrative
At this time the product has not been returned for investigation. Once the product is returned an investigation into the alleged accuracy issue will be performed. With an abundance of caution this report is being filed with the understanding of the potential patient harm that could be caused to the patient by an inaccurate device measurement.
 
Event Description
It was reported that the femoral and tibia cuts were made using the orhalign computer. After completion of cuts the surgeon thought the tibia cut looked like it had an anterior slope of around 10 degrees (the jig was dialed to zero degrees v/v and zero degrees posterior slope). He also thought the femoral cut was in too much flexion + in varus (jig was set to zero gegrees v/v and 3 degrees fem flexion). Tibia had to be recut with extramedullary guide.
 
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Brand NameORTHALIGN PLUS UNIT
Type of DeviceNAVIGATION 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 Key14824878
MDR Text Key295055653
Report Number3007521480-2022-00007
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 Health Professional,User Facility,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number403001-08
Device Catalogue Number403001
Device Lot Number210731018LS
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/22/2022
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: 06/26/2022 Patient Sequence Number: 1
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