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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT; LEFT FOSSA COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT; LEFT FOSSA COMPONENT Back to Search Results
Model Number TYY-NNNLF
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
The surgeon removed the left's fossa component.Several attempts have been made to collect more information.Supplememt report will be submitted when information is received.
 
Event Description
The surgeon removed the left fossa component.
 
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Brand Name
PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
Type of Device
LEFT FOSSA COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura 93003 7607
Manufacturer (Section G)
TMJ SOLUTIONS, INC.
6059 king drive
ventura 93003 7606
Manufacturer Contact
lorena lundeen
6059 king drive
ventura 93003-7607
8056503391
MDR Report Key10944125
MDR Text Key219489502
Report Number2031049-2020-00101
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 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date11/01/2010
Device Model NumberTYY-NNNLF
Device Catalogue NumberTYY-NNNLF
Device Lot NumberW14477
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2009
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;
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