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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 IMPLANTS
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANTS 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 Unspecified Infection (1930)
Date of Event 07/17/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The surgeon revised the right tmj implants due to infection.
 
Event or Problem Description
The patient's right tmj implants were removed due to infection.
 
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Brand Name
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Common Device Name
TEMPOROMANDIBULAR JOINT IMPLANTS
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura,
MDR Report Key10242824
Report Number2031049-2020-00043
Device Sequence Number2432616
Product Code LZD
UDI-Device IdentifierB004TYYNNNNM0
UDI-Public+B004TYYNNNNM0/$$7W40612
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 07/07/2020
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 Date03/01/2019
Device Model NumberTYY-NNNNM
Device Catalogue NumberTYY-NNNNM
Device Lot NumberW40612
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2020
Initial Report FDA Received Date07/07/2020
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 Age67 YR
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