INVISALIGN SYSTEM INVISALIGN SYSTEM - COMPREHENSIVE 8820

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number2953749-2020-00215
MDR Report Key9709010
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-13
Date of Report2020-02-06
Date of Event2019-08-01
Date Mfgr Received2020-01-15
Device Manufacturer Date2019-01-01
Date Added to Maude2020-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. RYAN HOFFMEISTER
Manufacturer Street2820 ORCHARD PARKWAY
Manufacturer CitySAN JOSE CA 95134
Manufacturer CountryUS
Manufacturer Postal95134
Manufacturer Phone4087891588
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINVISALIGN SYSTEM
Generic NameALIGNER, SEQUENTIAL
Product CodeNXC
Date Received2020-02-13
Model NumberINVISALIGN SYSTEM - COMPREHENSIVE
Catalog Number8820
Lot Number31103272
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerALIGN TECHNOLOGY, INC.
Manufacturer Address2820 ORCHARD PARKWAY SAN JOSE CA 95134 US 95134


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2020-02-13

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