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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS MICROBLOCK ASSEMBLY

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ORTHALIGN, INC. ORTHALIGN PLUS MICROBLOCK ASSEMBLY Back to Search Results
Model Number 402042
Device Problem Insufficient Information (3190)
Patient Problem Not Applicable (3189)
Event Date 06/07/2019
Event Type  malfunction  
Manufacturer Narrative
Orthalign, inc. Is filing this mdr in an abundance of caution with the understanding of the potential of an injury related to inaccurate instruments may cause in this type of orthopeadic surgery. An investigation will be preformed on the returned device. Once results and a conclusion is made available a follow-up will be filed.
 
Event Description
It was reported that there's too much "play" between the cutting guide and the microblock. Additional information provided indicated that the surgeon is questioning its accuracy.
 
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Brand NameORTHALIGN PLUS
Type of DeviceMICROBLOCK ASSEMBLY
Manufacturer (Section D)
ORTHALIGN, INC.
120 columbia
suite 500
aliso viejo CA 92656
Manufacturer Contact
katy nennig
120 columbia
suite 500
aliso viejo, CA 92656
9202546370
MDR Report Key8759818
MDR Text Key150009632
Report Number3007521480-2019-00014
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number402042
Device Catalogue Number402042
Device Lot Number16051201S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/23/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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