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

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.

• Brand Name: ORTHALIGN PLUS
• Type of Device: MICROBLOCK 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 Key: 8759818
• MDR Text Key: 150009632
• Report Number: 3007521480-2019-00014
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172462
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 402042
• Device Catalogue Number: 402042
• Device Lot Number: 16051201S
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 07/03/2019
• Supplement Dates Manufacturer Received: 06/07/2016
• Supplement Dates FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1