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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; RIGHT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT; RIGHT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNNLM
Medical Device Problem Code Patient Device Interaction Problem (4001)
Health Effect - Clinical Code Hypersensitivity/Allergic reaction (1907)
Date of Event 01/29/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The patient's tmj mandibular components were revised with all-titanium devices.Multiple mdr reports were filed for this event.Please see the associated report: 2031049-2020-00050.
 
Event or Problem Description
The patient's left mandibular component was removed and revised due to material sensitivity.
 
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Brand Name
PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
Common Device Name
RIGHT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura,
MDR Report Key10298202
Report Number2031049-2020-00051
Device Sequence Number11504308
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLM0
UDI-Public+B004TYYNNNNLM0/$$3190101W40258
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/20/2020
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 Date01/01/2019
Device Model NumberTYY-NNNNLM
Device Catalogue NumberTYY-NNNNLM
Device Lot NumberW40258
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/06/2020
Initial Report FDA Received Date07/20/2020
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 Age47 YR
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