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Model Number INVISALIGN SYSTEM - EXPRESS |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
Partial Hearing Loss (4472)
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Event Date 08/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.).
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Event Description
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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.
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Search Alerts/Recalls
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