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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT; LEFT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT; LEFT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNNLM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Hypersensitivity/Allergic reaction (1907)
Date of Event 02/23/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient developed swelling and pain in the preauricular area after receiving these implants.The surgeon decided to remove and replace the device with an all-titanium component.
 
Event or Problem Description
The surgeon removed and replaced the left mandibular component with an all-titanium device due to material hyper sensitivity.
 
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Brand Name
PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
Common Device Name
LEFT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura 93003 7607
MDR Report Key11375730
Report Number2031049-2021-00013
Device Sequence Number3781435
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLM0
UDI-Public+B004TYYNNNNLM0/$$3190201W40498
Combination Product (Y/N)N
Initial Reporter StateCA
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) 02/24/2021
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 Date02/01/2019
Device Model NumberTYY-NNNNLM
Device Catalogue NumberTYY-NNNNLM
Device Lot NumberW40498
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/23/2021
Initial Report FDA Received Date02/24/2021
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 Age39 YR
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