MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-13 for INVISALIGN SYSTEM INVISALIGN FULL 8629 manufactured by Align Technology, Inc..
[188341556]
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 a tooth extraction (permanent impairment to a body structure) and an align product was being used.
Patient Sequence No: 1, Text Type: N, H10
[188341557]
The patient reported cavities on tooth # 1 (upper right wisdom tooth) and 2 (upper right 2nd molar). The patient reported visiting a general dentist, who placed a filling on tooth # 2 and extracted tooth # 1, to alleviate the reported symptom. The patient did not report taking or being prescribed any medical intervention to alleviate the reported symptom. The treatment has not been discontinued as the patient is still wearing the aligners and is currently asymptomatic. The treating doctor reported a potential root cause of the event could have been the distalization in the treatment plan on the posterior segment, because tooth # 8 was distalized and space was opened, food was between the teeth, which caused cavities.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2020-00217 |
| MDR Report Key | 9709007 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-01-15 |
| Date of Event | 2019-07-01 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-02-08 |
| Date Added to Maude | 2020-02-13 |
| 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 |
| Manufacturer Phone | 4087891588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVISALIGN SYSTEM |
| Generic Name | ALIGNER, SEQUENTIAL |
| Product Code | NXC |
| Date Received | 2020-02-13 |
| Model Number | INVISALIGN FULL |
| Catalog Number | 8629 |
| Lot Number | 28254746 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Deathisabilit | 2020-02-13 |