MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-03-03 for TRANSCEND CERAMIC BRACKET 2001-602 manufactured by 3m Unitek.
[310350]
Orthodontist reported that while debonding transcend ceramic brackets in 1991, enamel damage down to dentin occurred on pt's right upper central tooth. The tooth was repaired with composite in 1991. However, a crown was placed on the tooth in 2004.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2004-00003 |
| MDR Report Key | 514418 |
| Report Source | 05 |
| Date Received | 2004-03-03 |
| Date of Report | 2004-02-19 |
| Date of Event | 1991-02-21 |
| Date Mfgr Received | 2004-02-19 |
| Date Added to Maude | 2004-03-08 |
| 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 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 | TRANSCEND CERAMIC BRACKET |
| Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Product Code | DYW |
| Date Received | 2004-03-03 |
| Model Number | NA |
| Catalog Number | 2001-602 |
| 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 | 503427 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | TRANSCEND-ROTH |
| Baseline Generic Name | CERAMIC BRACKET |
| Baseline Model No | NA |
| Baseline Catalog No | 2001-602 |
| Baseline ID | NA |
| Baseline Device Family | TRANSCEND (ORIGINAL) |
| Baseline Shelf Life Contained | A |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K861965 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-03-03 |