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 |