MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-11 for 3M UNITEK APC II GEMINI SL SELF-LIGATING BRACKET 3027-382 manufactured by 3m Unitek Corporaion.
[94481075]
The 3m unitek instructions for use state to instruct the patients not to chew or bite on hard substances such as hard candy, ice, carrots, etc. Careful and thorough patient instruction is key to avoiding appliance or enamel damage.
Patient Sequence No: 1, Text Type: N, H10
[94481076]
On (b)(4) 2017, 3m was notified by an orthodontist that a patient brought a 3m unitek apc ii gemini sl bracket (ll5) to the office which debonded from tooth #20 with a piece of tooth enamel attached. This bracket was the third bracket that had been bonded to the same tooth; the previous brackets had been bonded on (b)(6) 2016 and (b)(6) 2017, and the current bracket was bonded (b)(6) 2017. A non-3m brand primer was used during the bonding procedure. Upon follow-up by 3m, it was learned that the enamel damage was down to dentin. The patient admitted to eating hard pizza crust when the ll5 bracket came off. The orthodontist applied composite to fill in the affected area of enamel and re-bonded a non-3m brand bracket. The orthodontist plans to send the patient to their dentist for a permanent restoration at the end of orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
[117621919]
Per visual exam of the returned bracket, there is nothing unusual with the metal bracket or the shape of the bonding base; however, a thick adhesive layer with flash was still present and wrapped onto the top side of the bonding base. The mesh side of the bonding base was not visible due to the adhesive and enamel still attached. The 3m unitek instructions for use for apc ii adhesive, for bracket placement, indicates "gently remove excess adhesive around appliance base without disturbing the appliance. " based upon the visual evaluation of the returned bracket, it appears that the excess adhesive may not have been removed upon bracket placement, which may have contributed to this event. In addition, it cannot be ascertained if the use of non-3m brand primer may have contributed to this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2017-00006 |
| MDR Report Key | 7106467 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-11 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-11-27 |
| Date Mfgr Received | 2018-01-26 |
| Date Added to Maude | 2017-12-11 |
| 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 II GEMINI SL SELF-LIGATING BRACKET |
| Generic Name | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| Product Code | DYH |
| Date Received | 2017-12-11 |
| Returned To Mfg | 2017-12-11 |
| Catalog Number | 3027-382 |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-12-11 |