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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 Unspecified Infection (1930)
Date of Event 08/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This patient developed a draining fistula over the fossa.The surgeon removed the fossa component and implanted an antibiotic spacer.After the tissue is recovered, and the infection is resolved, the surgeon plans to place a new fossa component.
 
Event or Problem Description
The right fossa component was removed due to infection.
 
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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,
MDR Report Key10427110
Report Number2031049-2020-00074
Device Sequence Number14197044
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRF0
UDI-Public+B004TYYNNNNRF0/$$3160601W26373
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/19/2020
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 Date06/01/2016
Device Model NumberTYY-NNNRF
Device Catalogue NumberTYY-NNNRF
Device Lot NumberW26373
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2020
Initial Report FDA Received Date08/19/2020
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 Age23 YR
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