MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-08-01 for INVISALIGN SYSTEM INVISALIGN RETAINER 1011 manufactured by Align Technology, Inc..
[81559797]
No test methods have been performed (method 3323) as the product performed in accordance to specifications (conclusion 71) and the device was used in accordance with labeled indications (results 213). No conclusive evidence has been provided that supports or opposes that fact that the invisalign system aligners caused or contributed to the patients symptoms. This event is being filed as a mdr since the patient reported reported tooth loss (permanent impairment to a body structure) and the invisalign system aligners were being used at that time.
Patient Sequence No: 1, Text Type: N, H10
[81559798]
The patient reported symptoms of soreness tooth # 31 (lower right 2nd molar). The patient reported visiting a dentist, who extracted tooth 31, to alleviate the reported symptoms. It is unknown if the patient took or was prescribed any medication due to the reported symptoms. It is unknown if the treatment has been discontinued or if the patient is still wearing the invisalign retainers. The treating doctor did not consider the event was serious or life threatening to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2017-00691 |
| MDR Report Key | 6758908 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-08-01 |
| Date of Report | 2017-08-01 |
| Date of Event | 2016-05-01 |
| Date Mfgr Received | 2017-07-10 |
| Device Manufacturer Date | 2017-01-20 |
| Date Added to Maude | 2017-08-01 |
| 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 | 3 |
| Manufacturer Contact | MR. RYAN HOFFMEISTER |
| Manufacturer Street | 2560 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | MAINTAINER, SPACE PREFORMED, ORTHODONTIC |
| Product Code | DYT |
| Date Received | 2017-08-01 |
| Model Number | INVISALIGN RETAINER |
| Catalog Number | 1011 |
| Lot Number | 21189577 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY, INC. |
| Manufacturer Address | 2560 ORCHARD PARKWAY SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-08-01 |