MAUDE Adverse Event Report: ORMCO CORPORATION SPIRIT MB; ORTHODONTIC BRACKET, PLASTIC

Catalog Number 202-0069

Device Problems Nonstandard Device (1420); Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

A dealer reported that a doctor's office alleged that spirit mb identification dot is located on the incorrect area of the bracket.

Manufacturer Narrative

No injuries were associated with this incident.The doctor noticed the marking was in the wrong area and stopped using the device.Pictures of the product alleged in this incident confirmed that the identification dot is located on the incorrect area of the bracket.A retain sample of the product was evaluated, yielding results within specifications.

Manufacturer Narrative

Sybronendo corporation was informed on 04/14/2014 by a dealer representative that the wrong item number and description was given on the initial complaint report.The correct item number involved in the alleged incident is 202-0069 and the description is channels 21mm files.

• Brand Name: SPIRIT MB
• Type of Device: ORTHODONTIC BRACKET, PLASTIC
• Manufacturer (Section D): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer (Section G): ORMCO CORPORATION; 1332 south lone hill avenue; glendora CA 91740
• Manufacturer Contact: kerri casino ; 1717 w. collins ave; orange, CA 92867 ; 7145167634
• MDR Report Key: 3679839
• MDR Text Key: 4295108
• Report Number: 2016150-2014-00023
• Device Sequence Number: 1
• Product Code: DYW
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K943245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 202-0069
• Device Lot Number: 081351013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1