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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNRM
Device Problem Insufficient Information (3190)
Patient Problem Joint Disorder (2373)
Event Date 08/24/2017
Event Type  Injury  
Manufacturer Narrative
The patient's right tmj devices were removed for an unknown reason.No additional information was provided.Multiple reports were submitted for this event ( see associated report 2031049-2020-00061).
 
Event Description
The patient's right tmj devices were removed for an unknown reason.
 
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Brand Name
PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
Type of Device
RIGHT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura,
Manufacturer (Section G)
TMJ SOLUTIONS, INC.
6059 king drive
ventura,
Manufacturer Contact
lorena lundeen
6059 king drive
ventura, 
6503391
MDR Report Key10330282
MDR Text Key200854512
Report Number2031049-2020-00062
Device Sequence Number1
Product Code LZD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 07/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberTYY-NNNRM
Device Catalogue NumberTYY-NNNRM
Device Lot NumberW02194
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
Patient Age63 YR
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