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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS COMPUTER ASSISTED SURGERY SYSTEM

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ORTHALIGN, INC. ORTHALIGN PLUS COMPUTER ASSISTED SURGERY SYSTEM Back to Search Results
Model Number 403001
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 08/11/2017
Event Type  Injury  
Manufacturer Narrative
We reviewed the issue and initial procedure with the surgeon. No device defects or malfunctions were detected. No fracture or other complications were observed during the initial procedure. The orthalign plus device performed normally during the procedure. X-rays were not provided to orthalign. It is unclear where the fracture originated in the tibia. It is unclear what specifically caused the fracture.
 
Event Description
A surgeon reported that a patient who had undergone an unicompartmental knee arthroplasty procedure navigated by the orthalign plus system returned three and a half months later with a fracture in the tibia below the tibial resection. The fracture required a revision procedure with a long tibial stem to constrain the arthroplasty components and bypass the fracture site.
 
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Brand NameORTHALIGN PLUS
Type of DeviceCOMPUTER ASSISTED SURGERY SYSTEM
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
david vancelette
120 columbia, suite 500
aliso viejo, CA 92656
9495259034
MDR Report Key7011820
MDR Text Key91415829
Report Number3007521480-2017-00005
Device Sequence Number1
Product Code OLO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number403001
Device Catalogue Number403001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/26/2017
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/08/2017 Patient Sequence Number: 1
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