MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-12-20 for 3M UNITEK APC? FLASH-FREE CLARITY? ADVANCED MBT 4006-313 manufactured by 3m Unitek Corporaion.
[95405722]
The ifu for 3m unitek clarity advanced ceramic brackets does contain a warning that states "instruct patients not to chew or bite on hard substances such as hard candy, ice, carrots, etc. Careful and thorough patient instruction is a key to avoiding appliance or enamel damage. " since this event involved two medical devices, two manufacturer reports are being submitted. This report (2020467-2017-00007) represents the first medical device, and 2020467-2017-00008 represents the second device.
Patient Sequence No: 1, Text Type: N, H10
[95405723]
On (b)(6), 2017, 3m was notified that a (b)(6) old male patient had a 3m unitek apc flash-free clarity advanced upper left bicuspid bracket (ul5) debond from tooth #13 while eating an apple. The debonded bracket contained tooth enamel. The orthodontist removed the bracket that was still attached to the archwire and sent the patient to his dentist for restoration of the enamel. Upon 3m follow-up with the orthodontist, enamel damage down to dentin was reported. The bracket was initially placed on (b)(6) 2016. Other products used when the bracket was placed included a non-3m etchant and 3m unitek transbond plus self-etching primer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2017-00007 |
| MDR Report Key | 7134783 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-12-20 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-11-21 |
| Date Mfgr Received | 2017-11-30 |
| Date Added to Maude | 2017-12-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANGIE DRAPER |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517331179 |
| Manufacturer G1 | 3M UNITEK |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 910165097 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M UNITEK APC? FLASH-FREE CLARITY? ADVANCED MBT |
| Generic Name | BRACKET, CERAMIC, ORTHODONTIC |
| Product Code | NJM |
| Date Received | 2017-12-20 |
| Catalog Number | 4006-313 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK CORPORAION |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 910165097 US 910165097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-12-20 |