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 SYSTEM - COMPREHENSIVE 8820 manufactured by Align Technology, Inc..
[188341248]
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 the symptom a tooth extraction (permanent impairment to a body structure) and an align product was being used.
Patient Sequence No: 1, Text Type: N, H10
[188341249]
The patient reported symptoms of tooth pain on tooth # 2 (upper right 2nd molar), red and swollen cheeks, diagnosis of asymptomatic irreversible pulpitis, nerve pain on the upper right quadrant (unspecified teeth #), pain of the eye socket, swollen eyelid, required root canals on teeth # 3 (upper right 1st premolar), 8 (upper right central incisor) and 4 (upper right 2nd premolar), and extractions of tooth # 3, 4, 8, and 7 (upper right lateral incisor). These reported symptoms do not appear to be potentially serious in nature or life threatening to the patient, individually or as a combination of symptoms. The patient reported visiting the er, a dentist, endodontist and a general physician, and had a mri (showed no nerve damage), mra (showed no nerve damage) and a brain scan (results are unknown) performed. It is unspecified who extracted the patients teeth. The patient reported being prescribed amoxicillin (antibiotic) and augmentin (penicillin antibiotic) to alleviate the reported symptoms. The treatment was discontinued on (b)(6) 2019.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2953749-2020-00215 |
| MDR Report Key | 9709010 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-06 |
| Date of Event | 2019-08-01 |
| Date Mfgr Received | 2020-01-15 |
| Device Manufacturer Date | 2019-01-01 |
| 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 SYSTEM - COMPREHENSIVE |
| Catalog Number | 8820 |
| Lot Number | 31103272 |
| 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 |