MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-11-22 for APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBE 4069-5114 manufactured by 3m Unitek Corporaion.
[92838057]
Since two 3m unitek products were involved in this event, two manufacturer reports are being filed. The current manufacturer report is related to the first device and manufacturer report 2020467-2017-00004 is related to the second device.
Patient Sequence No: 1, Text Type: N, H10
[92838058]
On (b)(6) 2017, 3m was notified by an orthodontist that the top layer of enamel broke off a (b)(6) male patient's tooth (#3) upon debonding of a 3m unitek apc flash free victory series fit buccal tube. 3m unitek transbond plus self-etching primer was used to place the bracket. The orthodontist sent the patient to their dentist to have the tooth repaired. Upon follow-up by 3m with the orthodontist, it was learned that the enamel damage was down to dentin and the orthodontist reported that the tooth appeared to be normal prior to this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2017-00003 |
| MDR Report Key | 7054445 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-22 |
| Date of Event | 2017-09-27 |
| Date Mfgr Received | 2017-10-27 |
| Date Added to Maude | 2017-11-22 |
| 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 | APC FLASH-FREE VICTORY SERIES SUPERIOR FIT BUCCAL TUBE |
| Generic Name | ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN |
| Product Code | DYH |
| Date Received | 2017-11-22 |
| Catalog Number | 4069-5114 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-11-22 |