MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-09-26 for APC II CLARITY METAL LINED CERAMIC BRACKET 6700-611 manufactured by 3m Unitek.
[18158215]
The pt was playing football when an apc ii clarity bracket debonded from the upper bicuspid tooth. A piece of enamel 2 1/2 mm x 2 1/2 mm into dentin was removed from the tooth when the bracket debonded. Orthodontist said that tooth will be repaired with composite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2003-00004 |
| MDR Report Key | 486207 |
| Report Source | 05 |
| Date Received | 2003-09-26 |
| Date of Report | 2003-09-16 |
| Date of Event | 2003-08-01 |
| Date Mfgr Received | 2003-09-16 |
| Date Added to Maude | 2003-10-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK RD |
| 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 LINED CERAMIC BRACKET |
| Generic Name | ORTHODONTIC BRACKET |
| Product Code | DYW |
| Date Received | 2003-09-26 |
| Model Number | NA |
| Catalog Number | 6700-611 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 475092 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | APC II CLARITY METAL-REINFORCED CERAMIC BRKT |
| Baseline Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Baseline Model No | NA |
| Baseline Catalog No | 6700-611 |
| Baseline Device Family | CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | * |
| 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 | 2003-09-26 |