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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS DENTAL LAB SMILEDIRECTCLUB ALIGNER SYSTEM; SEQUENTIAL ALIGNER

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ACCESS DENTAL LAB SMILEDIRECTCLUB ALIGNER SYSTEM; SEQUENTIAL ALIGNER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Necrosis (1971)
Event Date 04/27/2021
Event Type  Injury  
Manufacturer Narrative
Based on the information provided by the patient, there is no conclusive evidence that supports or opposes the fact that the aligners caused, contributed, or would likely cause or contribute to the reported event.This event is being filed as an mdr since the patient reported symptoms or physiological conditions that led to necrosis of a tooth.As per capa #(b)(4) this event is retrospectively being reported and therefore was not reported within the required 30-days.
 
Event Description
The customer reported nerve damage while wearing the aligners, the customer was not able to provide the impacted tooth number.It is unknown if medical intervention was required.It is unknown if aligner treatment was discontinued.
 
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Brand Name
SMILEDIRECTCLUB ALIGNER SYSTEM
Type of Device
SEQUENTIAL ALIGNER
Manufacturer (Section D)
ACCESS DENTAL LAB
1530 antioch pike
antioch TN 37013
Manufacturer Contact
bernie silvers
1530 antioch pike
antioch, TN 37013
5127642249
MDR Report Key13118579
MDR Text Key282970743
Report Number3014658399-2021-01725
Device Sequence Number1
Product Code NXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Date Manufacturer Received04/27/2021
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age17 YR
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