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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT Back to Search Results
Model Number TYY-NNNNM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Disorder (2373)
Date of Event 10/25/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This patient received bilateral tmj implants in (b)(6) 2019.The patient developed discomfort and clicking on her left side.On (b)(6) 2019, the surgeon performed an exploratory surgery where he discovered synovial tissue between the fossa and condylar implants.The synovial tissue was removed.
 
Event or Problem Description
The surgeon removed synovial entrapment from the patient's left tmj.
 
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Brand Name
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Common Device Name
TEMPOROMANDIBULAR JOINT IMPLANT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura CA 93003 7398
MDR Report Key9666838
Report Number2031049-2020-00004
Device Sequence Number2535394
Product Code LZD
UDI-Device IdentifierB004TYYNNNNM0
UDI-Public+B004TYYNNNNM0/$$7W48083
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/03/2020
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 Date11/02/2020
Device Model NumberTYY-NNNNM
Device Catalogue NumberTYY-NNNNM
Device Lot NumberW48083
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/08/2020
Initial Report FDA Received Date02/04/2020
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 Age64 YR
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