MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-07-27 for CLARITY METAL-REINFORCED CERAMIC BRACKET 6400-637 manufactured by 3m Unitek.
[20681647]
While patient was playing volleyball, a clarity ceramic bracket debonded prematurely from patient's lower left second bicuspid, removing with it a piece of enamel from the buccal surface of the tooth. Per orthodontist, there was slight exposure of dentin. Orthodontist repaired tooth with composite filling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2001-00005 |
| MDR Report Key | 344154 |
| Date Received | 2001-07-27 |
| Date of Report | 2001-07-02 |
| Date of Event | 2001-06-18 |
| Date Mfgr Received | 2001-07-02 |
| Date Added to Maude | 2001-07-31 |
| 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 | CLARITY METAL-REINFORCED CERAMIC BRACKET |
| Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Product Code | DYW |
| Date Received | 2001-07-27 |
| Returned To Mfg | 2001-07-05 |
| Model Number | NA |
| Catalog Number | 6400-637 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 333484 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | CLARITY |
| Baseline Generic Name | OTHRODONTIC CERAMIC BRACKET |
| Baseline Catalog No | 6400-637 |
| Baseline ID | METAL REINFORCE |
| Baseline Device Family | CLARITY METAL REINFORCED CERAMIC BRACKET |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K944286 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-07-27 |