MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-07-22 for APC CLARITY METAL-REINFORCED CERAMIC BRACKET 6500-605 manufactured by 3m Unitek.
[19265218]
Orthodontist reported that during the debonding of an apc clarity ceramic bracket, tooth dentin was exposed when a piece of enamel (2mm in diameter and 2 mm in depth) was removed from a pt's upper left cuspid. Orthodontist stated that the tooth was in good condition prior to orthodontic treatment, that he used the correct technique and instrument for debonding the bracket. However, a remnant of the bracket base was left on the tooth, and orthodontist reported that he used a straight cutter to remove the bracket remnant. The instructions-for-use direct the orthodontist that "if a bracket fractures during treatment or debonding, use a diamond burr to remove the ceramic fragments". The tooth was repaired with composite material.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2002-00010 |
| MDR Report Key | 406506 |
| Report Source | 05 |
| Date Received | 2002-07-22 |
| Date of Report | 2002-06-24 |
| Date of Event | 2001-12-19 |
| Date Added to Maude | 2002-07-25 |
| 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 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 CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Product Code | DYW |
| Date Received | 2002-07-22 |
| Model Number | NA |
| Catalog Number | 6500-605 |
| 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 | 395493 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | APC CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Baseline Generic Name | ORTHODONTIC ADHESIVE AND CERAMIC BRACKET |
| Baseline Model No | NA |
| Baseline Catalog No | 6500-605 |
| Baseline Device Family | APC 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 | 2002-07-22 |