MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-09-24 for MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT 712-050 manufactured by 3m Unitek.
[81819]
Orthodontist reported that multi-cure glass ionomer orthodontic band cement was used to bond a herbst appliance, and that when the herbst appliance was debonded, a lingual cusp fractured. Pt's dentist advised on 01-28-1998 that the tooth required a crown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-1998-00006 |
| MDR Report Key | 189205 |
| Report Source | 05 |
| Date Received | 1998-09-24 |
| Date of Report | 1998-09-04 |
| Date of Event | 1997-05-15 |
| Date Mfgr Received | 1998-09-04 |
| Date Added to Maude | 1998-09-29 |
| 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 | MULTI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT |
| Generic Name | ORTHODONTIC BAND CEMENT |
| Product Code | DYH |
| Date Received | 1998-09-24 |
| Model Number | NA |
| Catalog Number | 712-050 |
| Lot Number | * |
| 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 | 183874 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | MULTI-CURE GI CEMEMT KIT |
| Baseline Generic Name | GLASS IONOMER BAND CEM |
| Baseline Model No | 712-050 |
| Baseline Catalog No | 712-050 |
| Baseline ID | NONE |
| Baseline Device Family | GLASS IONOMER CEMENT/ADHESIVE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K950514 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-09-24 |