MAUDE Adverse Event Report: ALIGN TECHNOLOGY, INC. INVISALIGN SYSTEM; ALIGNER, SEQUENTIAL

Model Number	INVISALIGN SYSTEM - EXPRESS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Partial Hearing Loss (4472)
Date of Event	08/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The current instructions for use (ifu) contain the following: "precautions - in rare instances, problems in the temporo-mandibular joint (temporo-mandibular disorder (tmd)) may result in joint pain, headaches, or ear problems.During forward posturing and vertical changes with mandibular advancement features, problems in the temporo-mandibular joint may be exacerbated." the treating doctor shared that there is no clear correlation between the reported event and the invisalign treatment as it may be purely coincidental.Per align's clinical assessment, the aligner treatment could have revealed or exacerbated a previously unknown medical issue (tmj), or the reported symptoms could be completely circumstantial to the patient's aligner treatment, and a more thorough medical examination would be necessary to solidify a causal relationship.Thus, there is no conclusive evidence that supports or opposes the fact that the invisalign aligners caused or contributed to the reported symptoms of hearing loss.This event is being filed as an mdr as the patient reported hearing loss and an invisalign product was being used.
Event or Problem Description
The patient reported symptoms of tinnitus, ringing in the ear, hearing loss (90% hearing loss in right ear and some hearing loss in left ear).The patient reported requiring visiting an audiologist to address the reported symptoms.The patient did not report requiring any prescription medications to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners (date unspecified) and is currently getting better.
Additional Manufacturer Narrative
B3: date of the event updated to 08/15/2023.The patient's reported symptoms could have started in (b)(6) (note in audiologist report and patient stage in treatment); however, no conclusive evidence is available to confirm the exact date.The 08/15/2023 date will be used to account for this estimated time range for date of event.B6: updated that the patient reported visiting an ent to alleviate the reported symptoms b7: updated patient's relevant history to include environmental noise exposure and pressure sensitivity additional manufacturer narrative: the patient reported that the ent shared that the reported symptoms of hearing loss may be related to the invisalign treatment, and the ent mentioned that there could be some relation between movement and clenching that worsened on the patient.(as previously stated in initial report: the current instructions for use (ifu) contain the following: "precautions - in rare instances, problems in the temporomandibular joint (temporo-mandibular disorder (tmd)) may result in joint pain, headaches, or ear problems.During forward posturing and vertical changes with mandibular advancement features, problems in the temporo-mandibular joint may be exacerbated." the treating doctor shared that there is no clear correlation between the reported event and the invisalign treatment as it may be purely coincidental.Per align's clinical assessment, the aligner treatment could have revealed or exacerbated a previously unknown medical issue (tmj), or the reported symptoms could be completely circumstantial to the patient's aligner treatment, and a more thorough medical examination would be necessary to solidify a causal relationship.Thus, there is no conclusive evidence that supports or opposes the fact that the invisalign aligners caused or contributed to the reported symptoms of hearing loss.This event is being filed as an mdr as the patient reported hearing loss and an invisalign product was being used.).
Event or Problem Description
The patient reported symptoms of tinnitus, ringing in the ear, hearing loss (90% hearing loss in right ear and some hearing loss in left ear).The patient reported requiring visiting an audiologist and an ent to address the reported symptoms.The patient did not report requiring any prescription medications to alleviate the reported symptoms.The patient reported discontinuing the use of the aligners (date unspecified) and is currently getting better.

• Brand Name: INVISALIGN SYSTEM
• Common Device Name: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer (Section G): ALIGN TECHNOLOGY, INC.; 2820 orchard parkway; san jose CA 95134
• Manufacturer Contact: harper shore ; 3030 slater road; morrisville, NC 27560 ; 4084701343
• MDR Report Key: 18252338
• Report Number: 2953749-2023-03347
• Device Sequence Number: 17787741
• Product Code: NXC
• UDI-Device Identifier: 00816063020219
• UDI-Public: (01)00816063020219(10)0155869513(13)230712(91)2113629104N
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K220287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: INVISALIGN SYSTEM - EXPRESS
• Device Catalogue Number: 9003
• Device Lot Number: 155869513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 12/01/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Male