MAUDE Adverse Event Report: ORMCO CORPORATION ORTHO SOLO

Catalog Number 740-0271

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Sensitivity of Teeth (2427)

Event Date 05/04/2017

Event Type  Injury  

Manufacturer Narrative

It was alleged that a patient lost enamel to teeth.It was confirmed that no serious injury was associated with this incident.The doctor fixed the patients teeth that lost the enamel and a new device was replaced.To date the patient is doing fine.

Event Description

It was alleged that a patient lost enamel to teeth while using ortho solo.

Manufacturer Narrative

The product involved in the alleged incident was not returned; therefore, a retain sample was evaluated, yielding results within specifications.

Event Description

It was alleged that a patient lost enamel to teeth while using ortho solo.

• Brand Name: ORTHO SOLO
• Type of Device: ORTHO SOLO
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill ave.; glendora CA 91740
• Manufacturer Contact: suzette rampair-johnson ; 1332 south lone hill ave.; glendora, CA 91740 ; 9099625730
• MDR Report Key: 6649985
• MDR Text Key: 77863822
• Report Number: 2016150-2017-00001
• Device Sequence Number: 1
• Product Code: DYH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 740-0271
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other