MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-22 for 3M UNITEK APC II? CLARITY? ADVANCED MBT CERAMIC BRACKET 3006-359 manufactured by 3m Unitek Corporation.
[112094875]
This event may be related to the previously compromised restoration of the tooth. Since this event involved two medical devices, two manufacturer reports are being submitted. This report (2020467-2018-00003) represents the first medical device, and 2020467-2018-00004 represents the second device.
Patient Sequence No: 1, Text Type: N, H10
[112094876]
On (b)(6) 2018, 3m was notified that a female patient, approximately (b)(6), had a large buccal filling break off from a previously restored upper pre-molar tooth upon debonding of a 3m apc ii clarity advanced ceramic bracket. The break was reported to be down to dentin. The bracket had been in place for approximately 18 months. The orthodontist reported that the large filling/restoration on the tooth did not look normal. Other products used when the bracket was initially bonded included a non-3m brand etchant. In addition, although the brand of the primer or catalog number was not disclosed by the reporting facility, based upon a description of the product and sales history, it is suspected that 3m transbond plus self etching primer was also potentially used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2018-00003 |
| MDR Report Key | 7631089 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-31 |
| Date Mfgr Received | 2018-06-01 |
| Date Added to Maude | 2018-06-22 |
| 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 | MARK BURVILLE |
| Manufacturer Street | 2510 CONWAY AVENUE |
| Manufacturer City | ST. PAUL, |
| 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? CLARITY? ADVANCED MBT CERAMIC BRACKET |
| Generic Name | BRACKET, CERAMIC, ORTHODONTIC |
| Product Code | NJM |
| Date Received | 2018-06-22 |
| Catalog Number | 3006-359 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK CORPORATION |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 910165097 US 910165097 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-06-22 |