MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-01-10 for TRANSCEND CERAMIC BRACKET UNK 2000-607 manufactured by 3m Unitek.
[33514]
Orthodontist stated that while debonding a transcend ceramic bracket from tooth #11, the tooth fractured at the gingival one-third on the facial and subgingival on the lingual and distal. Follow-up therapy included endodontic treatment and a crown.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2020467-1997-00001 |
MDR Report Key | 63245 |
Report Source | 05 |
Date Received | 1997-01-10 |
Date of Report | 1996-12-16 |
Date of Event | 1996-12-12 |
Date Mfgr Received | 1996-12-16 |
Date Added to Maude | 1997-01-22 |
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 CERAMIC BRACKET |
Generic Name | ORTHODONTIC CERAMIC BRACKET |
Product Code | ECQ |
Date Received | 1997-01-10 |
Model Number | UNK |
Catalog Number | 2000-607 |
Lot Number | UNK |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Age | * |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 63426 |
Manufacturer | 3M UNITEK |
Manufacturer Address | 2724 SOUTH PECK RD MONROVIA CA 91016 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1997-01-10 |