MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-17 for TRANSCEND 2300-604 manufactured by 3m Unitek.
[20521953]
Orthodontist reported that while debonding transcend ceramic brackets in 1994, a horizontal fracture occurred on the upper right lateral incisor. The tooth became necrotic some time later and subsequently required root canal therapy in 1998.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-1998-00005 |
| MDR Report Key | 187803 |
| Report Source | 05 |
| Date Received | 1998-09-17 |
| Date of Report | 1998-09-10 |
| Date of Event | 1994-04-08 |
| Date Mfgr Received | 1998-09-10 |
| Date Added to Maude | 1998-09-21 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANSCEND |
| Generic Name | ORTHODONTIC CERAMIC BRACKET |
| Product Code | DYW |
| Date Received | 1998-09-17 |
| Model Number | NA |
| Catalog Number | 2300-604 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 182520 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | TRANSCEND |
| Baseline Generic Name | CERAMIC BRACKET |
| Baseline Model No | * |
| Baseline Catalog No | 2300-604 |
| Baseline ID | SERIES 6000 |
| Baseline Device Family | TRANSCEND |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| 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 | 3 | 1. Required No Informationntervention | 1998-09-17 |