MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-01-11 for APC II CLARITY METAL-REINFORCED CERAMIC BRACKET 6700-609 manufactured by 3m Unitek.
[383973]
Orthodontist stated that during the debonding of clarity ceramic brackets, all of the brackets debonded easily except for the bracket on pt's upper left second bicuspid tooth. After debonding this bracket, orthodontist observed that a piece of enamel down-to-dentin was attached to the bracket base. Orthodontist stated that pt's tooth has been repaired with composite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2005-00001 |
| MDR Report Key | 564515 |
| Report Source | 05 |
| Date Received | 2005-01-11 |
| Date of Report | 2004-12-28 |
| Date of Event | 2004-11-22 |
| Date Mfgr Received | 2004-12-28 |
| Date Added to Maude | 2005-01-12 |
| 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 | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | APC II CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Generic Name | ORTHODONTIC BRACKET |
| Product Code | DYW |
| Date Received | 2005-01-11 |
| Model Number | NA |
| Catalog Number | 6700-609 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 554269 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | APC II CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Baseline Generic Name | ORTHODONTIC ADHESIVE AND CERAMIC BRACKET |
| Baseline Model No | NA |
| Baseline Catalog No | 6700-609 |
| Baseline Device Family | APC II CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911271 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-01-11 |