MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-01-20 for ADVANSYNC manufactured by Ormco Corporation.
[2465761]
A doctor reported that the advansync appliance was causing the inside of a patient's left cheek to be cut up.
Patient Sequence No: 1, Text Type: D, B5
[9529879]
The patient was prescribed an antibiotic (amoxicillin) for treatment of the patient's cheek. To date, the patient is doing fine and has fully recovered. Modifications to the existing appliance will be made with regard to patient comfort.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2016150-2012-00006 |
| MDR Report Key | 2424282 |
| Report Source | 05 |
| Date Received | 2012-01-20 |
| Date of Report | 2011-12-21 |
| Date Mfgr Received | 2011-12-21 |
| Date Added to Maude | 2012-01-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. ORLANDO TADEO, JR. |
| Manufacturer Street | 1717 W. COLLINS AVE. |
| Manufacturer City | ORANGE CA 92867 |
| Manufacturer Country | US |
| Manufacturer Postal | 92867 |
| Manufacturer Phone | 7145167419 |
| Manufacturer G1 | ORMCO CORPORATION |
| Manufacturer Street | 1332 SOUTH LONE HILL AVENUE |
| Manufacturer City | GLENDORA CA 91740 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91740 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVANSYNC |
| Generic Name | BITE-JUMPING ORTHODONTIC APPLIANCE |
| Product Code | EJF |
| Date Received | 2012-01-20 |
| ID Number | WO # 3449143/3484517 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORMCO CORPORATION |
| Manufacturer Address | 1332 SOUTH LONE HILL AVENUE GLENDORA CA 91740 US 91740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-01-20 |