MAUDE Adverse Event Report: 3M UNITEK CORPORATION UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT; ORTHODONTIC ADHESIVE

Catalog Number 712-050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/21/2015

Event Type  Injury  

Event Description

Adolescent female who started orthodontic treatment in 2014 went to the orthodontist complaining of a toothache on tooth 26 (upper left 1st molar).In order to x-ray the tooth, the molar band was removed.When the band was removed, dental caries (tooth decay) was discovered that affected the tooth's pulp chamber, on the gingival/lingual side of the molar.This was very likely the cause of the patient's toothache.The patient's oral hygiene was described as "medium" by the orthodontist.Dental caries is the result of bacteria-induced breakdown of the hard tissues of the tooth by progressive local demineralization.The cause of the caries was likely a lack of thorough oral hygiene, as plaque can build up around orthodontic appliances.Because the hard tissues of the tooth were broken down by the caries, the removal of the band caused the cavity to appear in the tooth.There is no reason to believe that there was a malfunction of the glass ionomer band cement.

• Brand Name: UNITEK(TM) MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT
• Type of Device: ORTHODONTIC ADHESIVE
• Manufacturer (Section D): 3M UNITEK CORPORATION; 2724 south peck road; monrovia CA 91016 5097
• Manufacturer (Section G): 3M UNITEK CORPORATION; 2724 south peck road; monrovia CA 91016 5097
• Manufacturer Contact: kathleen bacon ; 2724 south peck road; monrovia, CA 91016-5097 ; 6265744212
• MDR Report Key: 5185770
• MDR Text Key: 29792423
• Report Number: 2020467-2015-00001
• Device Sequence Number: 1
• Product Code: DYH
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K950514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: 712-050
• Device Lot Number: GF9VB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR