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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNRM
Medical Device Problem Codes Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The surgeon plans on revising the joint.
 
Event or Problem Description
The surgeon reported that the patient's right ramus has resorbed due to a rare bone metabolism disorder.
 
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Brand Name
PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
Common Device Name
RIGHT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, LLC.
6059 king drive
ventura 93003 7607
MDR Report Key12163474
Report Number2031049-2021-00046
Device Sequence Number3713713
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRM0
UDI-Public+B004TYYNNNNRM0/$$3110401W15301
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2009
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) 07/13/2021
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 Date04/01/2011
Device Model NumberTYY-NNNRM
Device Catalogue NumberTYY-NNNRM
Device Lot NumberW15301
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/22/2021
Initial Report FDA Received Date07/13/2021
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;
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