MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-04-24 for TRANSCEND UNK manufactured by 3m Unitex.
[96605]
Orthodontist stated that the enamel damage down-to-dentin on tooth #10 occurred when ceramic bracket debonded during archwire removal. Orthodontist repaired tooth with resin material and rebonded another bracket. Orthodontist stated that the tooth may require restoration at the end of orthodontic treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-1998-00003 |
| MDR Report Key | 164599 |
| Report Source | 05 |
| Date Received | 1998-04-24 |
| Date of Report | 1998-03-31 |
| Date of Event | 1998-03-26 |
| Date Mfgr Received | 1998-03-31 |
| Date Added to Maude | 1998-04-29 |
| 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 | 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 | ECQ |
| Date Received | 1998-04-24 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 160212 |
| Manufacturer | 3M UNITEX |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-04-24 |