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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ACCESS DENTAL LAB SMILEDIRECTCLUB RETAINER

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ACCESS DENTAL LAB SMILEDIRECTCLUB RETAINER Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/23/2020
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 related to bone loss.
 
Event Description
The customer reported bone loss front top and bottom teeth while wearing the retainers.Medical intervention will be required, and a gum graft and implant will be performed.Aligner treatment was discontinued.For this event, the patient identifier is (b)(6) and the complaint number is (b)(4).
 
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Brand Name
SMILEDIRECTCLUB RETAINER
Type of Device
RETAINER
Manufacturer (Section D)
ACCESS DENTAL LAB
1530 antioch pike
antioch TN 37013
Manufacturer Contact
ceasar
1530 antioch pike   
antioch, TN 37013
7135918304
MDR Report Key17607190
MDR Text Key321779957
Report Number3014658399-2023-00117
Device Sequence Number1
Product Code DYT
UDI-Public(01)00850007728XXX
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K191990
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/23/2023
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
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/01/2023
Initial Date FDA Received08/23/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
Patient Age28 YR
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