MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-27 for INVISALIGN SYSTEM VIVERA RETAINER 8580 manufactured by Align Technology, Inc..
[70973351]
No test methods have been performed as the product performed in accordance to specifications and the device was used in accordance with labeled indications. No conclusive evidence has been provided that supports or opposes that fact that the invisalign system retainer caused or contributed to the patients symptoms. This event is being filed as a mdr because the patients teeth where extracted (permanent damage to a body structure) and invisalign system product was being used at that time. Device returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[70973352]
The patient reported the symptom of root fracture on tooth # 9 (upper left central incisor), root resorption, class ii tooth mobility and teeth # 9 and 10 (upper left lateral incisor) were extracted. The patient reported visiting a general dentist, who took x-rays that showed root resorption on teeth # 9 and 10 and also showed a fracture on tooth # 9. The general dentist decided to extract teeth # 9 and 10. It is unknown if the patient took or was prescribed any medication to alleviate the reported symptoms. The treatment has not been discontinued as the patient is still wearing the retainers. The treating doctor considered the event was serious but not life threatening to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2017-00268 |
| MDR Report Key | 6437700 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-27 |
| Date of Report | 2017-03-27 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-14 |
| Device Manufacturer Date | 2017-01-14 |
| Date Added to Maude | 2017-03-27 |
| 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 | 2017-03-27 |
| Model Number | VIVERA RETAINER |
| Catalog Number | 8580 |
| Lot Number | 21147545 |
| 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 | 2560 ORCHARD PARKWAY SAN JOSE CA 95131 US 95131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-27 |