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 2016-03-18 for APC II CLARITY ADVANCED CERAMIC BRACKET 3006-313 manufactured by 3m Unitek Corporation.
[40692368]
Patient stated she had no idea how or when the incident happened. The bracket did not fall off, as if the bond failed, there would be no enamel damage. Some sort of force had to be applied to dislodge the bracket and enamel from the tooth. Orthodontists routinely caution patients with ceramic brackets not to chew or bite anything hard. The ifu for clarity advanced brackets contains a warning: "instruct patients not to chew or bite on hard substances such as hard candy, ice, carrots, etc. Careful and thorough patient instruction is the key to avoiding appliance or enamel damage. " when ceramic brackets are debonded properly by the orthodontist, enamel damage rarely occurs. It is surmised that the cause of the incident was the patient biting/chewing something hard.
Patient Sequence No: 1, Text Type: N, H10
[40692369]
Patient went to orthodontist for repair of a loose bracket, which was still attached to the archwire. The bracket had debonded and a piece of enamel remained on the bracket base. According to the orthodontist, the damage was deep into dentin. He bonded the broken piece of enamel, still attached to the bracket, back into place on the tooth.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2016-00002 |
| MDR Report Key | 5510773 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-03-18 |
| Date of Report | 2016-02-24 |
| Date of Event | 2016-02-24 |
| Date Mfgr Received | 2016-02-24 |
| Date Added to Maude | 2016-03-18 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK RD |
| Manufacturer City | MONROVIA CA 910165097 |
| Manufacturer Country | US |
| Manufacturer Postal | 910165097 |
| Manufacturer Phone | 6265744212 |
| Manufacturer G1 | 3M UNITEK CORPORATION |
| 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 II CLARITY ADVANCED CERAMIC BRACKET |
| Generic Name | CERAMIC BRACKET |
| Product Code | NJM |
| Date Received | 2016-03-18 |
| Catalog Number | 3006-313 |
| Operator | DENTIST |
| 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 | 2016-03-18 |