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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT; RIGHT FOSSA COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT; RIGHT FOSSA COMPONENT Back to Search Results
Model Number TYY-NNNRF
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 09/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient's right fossa component was removed along with the previously revised mandibular component from another manufacturer (see mfr # 2031049-2020-00080).The patient's surgeon plans to place revision fossa and mandibular devices in a few months.
 
Event or Problem Description
The patient's right fossa component was removed due to pain and revised surgery.
 
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Brand Name
PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
Common Device Name
RIGHT FOSSA COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura 93003 7607
MDR Report Key10505547
Report Number2031049-2020-00081
Device Sequence Number1270526
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRF0
UDI-Public+B004TYYNNNNRF0/$$3150701W26671
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/08/2020
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 Date07/01/2015
Device Model NumberTYY-NNNRF
Device Catalogue NumberTYY-NNNRF
Device Lot NumberW26671
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/02/2020
Initial Report FDA Received Date09/08/2020
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 Age32 YR
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