MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-04-17 for TRANSCEND UNK manufactured by 3m Unitek.
[48456]
Orthodontist stated that while debonding a ceramic bracket, pt's tooth broke.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-1997-00004 |
| MDR Report Key | 85870 |
| Report Source | 05 |
| Date Received | 1997-04-17 |
| Date of Report | 1997-03-20 |
| Date of Event | 1996-10-01 |
| Date Mfgr Received | 1997-03-20 |
| Date Added to Maude | 1997-04-24 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 1997-04-17 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 85078 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK ROAD MONROVIA CA 91016 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-17 |