MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-08-01 for CONCISE ORTHODONTIC ADHESIVE 196-001 manufactured by 3m Unitek.
[20766242]
Orthodontist reported that enamel damage down-to-dentin, exposing the root canal, occurred on pt's lower right lateral tooth when he debonded an ormco orthodontics' stainless steel bracket which was bonded with concise orthodntic adhesive. Orthodonist stated that he has used the adhesive and debonding instrument involved in this event for 20 years without mishap. Pt's tooth has been repaired with composite.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020467-2003-00002 |
| MDR Report Key | 475262 |
| Report Source | 05 |
| Date Received | 2003-08-01 |
| Date of Report | 2003-07-24 |
| Date of Event | 2003-07-22 |
| Date Mfgr Received | 2003-07-24 |
| Date Added to Maude | 2003-08-05 |
| 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 | 3 |
| 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 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONCISE ORTHODONTIC ADHESIVE |
| Generic Name | ORTHODONTIC |
| Product Code | DYH |
| Date Received | 2003-08-01 |
| Model Number | NA |
| Catalog Number | 196-001 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 464118 |
| Manufacturer | 3M UNITEK |
| Manufacturer Address | 2724 SOUTH PECK RD. MONROVIA CA 91016 US |
| Baseline Brand Name | CONCISE ORTHODONTIC ADHESIVE |
| Baseline Generic Name | ORTHODONTIC ADHESIVE |
| Baseline Model No | NA |
| Baseline Catalog No | 196-001 |
| Baseline Device Family | CONCISE ORTHODONTIC ADHESIVE |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-01 |