MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2013-09-12 for APC FLASH FREE CLARITY SL CERAMIC BRACKET 4007-441 manufactured by 3m Unitek.
[16219204]
Patient with orthodontic ceramic brackets ate a date with a walnut in it. When she bit down, the lower left 2nd bicuspid bracket broke away from the tooth, taking enamel with it. The enamel damage was down to dentin, and the patient was referred to a dentist, who restored the tooth using a resin composite. The orthodontist banded the affected tooth so that orthodontic treatment could continue.
Patient Sequence No: 1, Text Type: D, B5
[16429596]
General precautions given by orthodontists to patients include avoidance of eating any hard or sticky foods. The patient ate a date with a walnut in it, and the bracket breaking off the tooth as a known possible consequence. In addition, the device instructions for use to the orthodontist (the user) state "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. " this occurrence is mdr reportable due to our internal procedure for any enamel damage down to dentin.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020467-2013-00001 |
| MDR Report Key | 3435416 |
| Report Source | 05 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-08-15 |
| Date of Event | 2013-08-08 |
| Date Mfgr Received | 2013-08-15 |
| Device Manufacturer Date | 2013-02-01 |
| Date Added to Maude | 2013-10-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KATHLEEN BACON |
| Manufacturer Street | 2724 SOUTH PECK RD. |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC FLASH FREE CLARITY SL CERAMIC BRACKET |
| Generic Name | BRACKET , CERAMIC ORTHODONTIC (NJM) |
| Product Code | NJM |
| Date Received | 2013-09-12 |
| Model Number | NA |
| Catalog Number | 4007-441 |
| Lot Number | DQ7QP |
| ID Number | KIT # 4007-110 |
| Device Expiration Date | 2014-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US 91016 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-09-12 |