MAUDE Adverse Event Report: 3M UNITEK CORPORATION INCOGNITO(TM); BRACKET, METAL, ORTHODONTIC

Catalog Number 358-111

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Tooth Fracture (2428)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

Patient is described by orthodontist as having a tight bite and there is no doubt he clenches his teeth.The lingual brackets were debonded on (b)(6) 2016 and patient is continuing treatment with a removable orthodontic appliance.

Event Description

Adult male in orthodontic treatment using lingual brackets, orthodontist reported a broken tooth, the upper right 1st bicuspid.There was a crown on this tooth.The lingual cusp had sheared off, the buccal portion was left intact.When the patient finishes orthodontic treatment, this tooth will be extracted and replaced with an implant.In speaking with the doctor, she mentioned a prior tooth breakage, the upper left 2nd molar.This tooth also had a crown.The tooth broke off at the gumline and was extracted by an oral surgeon in (b)(6) 2015.This was not reported to the manufacturer at the time.

• Brand Name: INCOGNITO(TM)
• Type of Device: BRACKET, METAL, ORTHODONTIC
• 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: 5446874
• MDR Text Key: 38557559
• Report Number: 2020467-2016-00001
• Device Sequence Number: 1
• Product Code: EJF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 358-111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2015
• Is the Device Single Use?: Yes
• 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: 40 YR