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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
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TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT Back to Search Results
Model Number TYY-NNNNLF
Medical Device Problem Codes Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 10/21/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient requested removal and exploration of her devices due to neuropathic pain and to prevent potential nerve injury.The surgeon plans to replace it soon.Several mdrs were submitted for this event (2031049-2021-00022).
 
Event or Problem Description
The left fossa component was removed due to malposition.
 
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Brand Name
PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
Common Device Name
LEFT FOSSA COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, LLC.
6059 king drive
ventura 93003 7607
MDR Report Key11674297
Report Number2031049-2021-00023
Device Sequence Number3052191
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLF0
UDI-Public+B004TYYNNNNLF0/$$3190601W42065
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/15/2021
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
Operator of Device Health Professional
Device Expiration Date06/01/2019
Device Model NumberTYY-NNNNLF
Device Catalogue NumberTYY-NNNNLF
Device Lot NumberW42065
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date04/15/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age51 YR
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