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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; LEFT TEMPOROMANDIBULAR JOINT IMPLANT
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TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; LEFT TEMPOROMANDIBULAR JOINT IMPLANT Back to Search Results
Model Number TYY-NNNM
Medical Device Problem Code Loss of Osseointegration (2408)
Health Effect - Clinical Code Osteolysis (2377)
Date of Event 04/19/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A ct scan was taken and showed that this patient had bone loss under the fossa component.The patient was diagnosed with chronic mastoiditis, and it was reported that the left tmj implants were removed.No additional patient consequences were reported.
 
Event or Problem Description
The patient left tmj devices were removed due to malposition secondary to chronic mastoiditis.
 
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Brand Name
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Common Device Name
LEFT TEMPOROMANDIBULAR JOINT IMPLANT
Manufacturer (Section D)
TMJ SOLUTIONS, LLC.
6059 king drive
ventura 93003 7607
MDR Report Key12041310
Report Number2031049-2021-00041
Device Sequence Number11765712
Product Code LZD
UDI-Device IdentifierB004TYYNNNNM0
UDI-Public+B004TYYNNNNM0/$$7W31422
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/21/2021
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 Date12/01/2016
Device Model NumberTYY-NNNM
Device Catalogue NumberTYY-NNNM
Device Lot NumberW31422
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/17/2021
Initial Report FDA Received Date06/22/2021
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 Age33 YR
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