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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 Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Ankylosis (4527); Implant Pain (4561)
Date of Event 08/30/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The surgeon reported that the devices were well functional and well-secured.
 
Event or Problem Description
The patient developed heterotopic bone around the right mandibular component.The surgeon debrided the joint.
 
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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 Key12437126
Report Number2031049-2021-00060
Device Sequence Number14665929
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRM0
UDI-Public+B004TYYNNNNRM0/$$3100101W13167
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 Year2008
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/29/2021
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 Date01/01/2010
Device Model NumberTYY-NNNRM
Device Catalogue NumberTYY-NNNRM
Device Lot NumberW13167
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/20/2021
Supplement Date Received by Manufacturer08/20/2021
Initial Report FDA Received Date09/07/2021
Supplement Report FDA Received Date09/29/2021
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 Age57 YR
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