MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-09-24 for MULTI-CURE GLASS LONOMER BAND CEMENT 712-050 manufactured by 3m Unitek.
[17417242]
Orthodontist reported that they had used multi-cure glass lonomer orthodontic band cement to bond stainless steel crowns to patient's molar teeth and then to attach a herbst appliance to the crown. Upon debonding the crown on tooth #30 (lower right first molar), one of the cusps was removed which resulted in exposed dentin. The tooth was repaired with sealant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2001-00006 |
| MDR Report Key | 353294 |
| Report Source | 05 |
| Date Received | 2001-09-24 |
| Date of Report | 2001-08-31 |
| Date of Event | 2001-08-23 |
| Date Mfgr Received | 2001-08-31 |
| Date Added to Maude | 2001-09-28 |
| 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 |
| Manufacturer Contact | MARLYN SCHEFF |
| Manufacturer Street | 2724 SOUTH PECK ROAD |
| Manufacturer City | MONROVIA CA 91016 |
| Manufacturer Country | US |
| Manufacturer Postal | 91016 |
| Manufacturer Phone | 6265744496 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MULTI-CURE GLASS LONOMER BAND CEMENT |
| Generic Name | ORTHODONTIC BAND CEMENT |
| Product Code | DYH |
| Date Received | 2001-09-24 |
| Model Number | NA |
| Catalog Number | 712-050 |
| 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 | 342534 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK ROAD 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 | 2001-09-24 |