MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-12-11 for INVISALIGN SYSTEM VIVERA RETAINER 8579 manufactured by Align Technology, Inc..
[130115738]
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 an mdr as the patient reported an losing an entire dental implant while an invisalign product was being used. This psa has exceeded the 30 day calendar completion guideline, as this complaint was received on october 23, 2018, and was not reported to the appropriate department until november 26, 2018.
Patient Sequence No: 1, Text Type: N, H10
[130115739]
The patient reported a loss of a dental restoration (implant). The patient did not report requiring any medical intervention to alleviate the reported symptom. The patient did not report requiring any medication to alleviate the reported symptom. The treatment has not been discontinued as the patient is still wearing the retainers.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2018-02230 |
| MDR Report Key | 8153403 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-12-11 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2018-10-23 |
| Device Manufacturer Date | 2017-10-18 |
| Date Added to Maude | 2018-12-11 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. RYAN HOFFMEISTER |
| Manufacturer Street | 2820 ORCHARD PARKWAY |
| Manufacturer City | SAN JOSE CA 95134 |
| Manufacturer Country | US |
| Manufacturer Postal | 95134 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | MAINTAINER, SPACE PREFORMED |
| Product Code | DYT |
| Date Received | 2018-12-11 |
| Model Number | VIVERA RETAINER |
| Catalog Number | 8579 |
| Lot Number | 23406987 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALIGN TECHNOLOGY, INC. |
| Manufacturer Address | 2820 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-11 |