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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT
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TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT Back to Search Results
Model Number TYY-NNNNM
Medical Device Problem Codes Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Loss of Range of Motion (2032); Implant Pain (4561)
Date of Event 03/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient presented with pain and restricted mouth opening.The surgeon removed the devices and reported that the right fossa component was placed more laterally than the designed position.The surgeon plans to revise the devices.
 
Event or Problem Description
The patient's tmj devices were removed due to infection and malposition.
 
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Brand Name
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Common Device Name
TEMPOROMANDIBULAR JOINT IMPLANT
Manufacturer (Section D)
TMJ SOLUTIONS, LLC.
6059 king drive
ventura 93003 7607
MDR Report Key12207790
Report Number2031049-2021-00050
Device Sequence Number11865165
Product Code LZD
UDI-Device IdentifierB004TYYNNNNM0
UDI-Public+B004TYYNNNNM0/$$7W40099
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2021
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) 07/21/2021
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 Date07/01/2019
Device Model NumberTYY-NNNNM
Device Catalogue NumberTYY-NNNNM
Device Lot NumberW40099
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2021
Initial Report FDA Received Date07/21/2021
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 Age47 YR
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