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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 Loose or Intermittent Connection (1371); Connection Problem (2900); Osseointegration Problem (3003)
Health Effect - Clinical Code Inadequate Osseointegration (2646)
Date of Event 05/27/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The surgeon reported that the patient's mandibular bone screws were loosened and had fractured.The surgeon removed and replaced the right mandibular component with a revised device and performed an sso on the contralateral side.No additional information was provided.
 
Event or Problem Description
The surgeon removed the right mandibular component, debrided the joint, and placed a mandibular revision device.
 
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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 Key11925683
Report Number2031049-2021-00035
Device Sequence Number923765
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRM0
UDI-Public+B004TYYNNNNRM0/$$3150701W26649
Combination Product (Y/N)N
Initial Reporter StateVT
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2013
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) 06/02/2021
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 Date07/01/2015
Device Model NumberTYY-NNNRM
Device Catalogue NumberTYY-NNNRM
Device Lot NumberW26649
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/02/2021
Initial Report FDA Received Date06/02/2021
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 Age29 YR
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