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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT; RIGHT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT; RIGHT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNRM
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Code Hypersensitivity/Allergic reaction (1907)
Date of Event 11/21/2017
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient's right mandibular component was removed and revised with another manufacturer's device.
 
Event or Problem Description
The patient's right mandibular component was removed due to suspected to material sensitivity.
 
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Brand Name
PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
Common Device Name
RIGHT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura 93003 7607
MDR Report Key10505534
Report Number2031049-2020-00080
Device Sequence Number3198047
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRM0
UDI-Public+B004TYYNNNNRM0/$$3150701W26672
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
Device Explanted Year2017
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/08/2020
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 Date07/01/2015
Device Model NumberTYY-NNNRM
Device Catalogue NumberTYY-NNNRM
Device Lot NumberW26672
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/02/2020
Initial Report FDA Received Date09/08/2020
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 Age29 YR
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