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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
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNLM
Medical Device Problem Code Malposition of Device (2616)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 08/24/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Several attempts have been made to collect the revision surgery date, but no additional information is available at this time.
 
Event or Problem Description
The surgeon plans to revise this patient's left mandibular component due to dislocation secondary to malpositioning.
 
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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 Key10857505
Report Number2031049-2020-00094
Device Sequence Number4001546
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLM0
UDI-Public+B004TYYNNNNLM0/$$3170601W33070
Combination Product (Y/N)N
Initial Reporter CountryFI
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
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) 11/18/2020
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 Date06/01/2017
Device Model NumberTYY-NNNLM
Device Catalogue NumberTYY-NNNLM
Device Lot NumberW33070
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/17/2020
Supplement Date Received by Manufacturer11/17/2020
Initial Report FDA Received Date11/17/2020
Supplement Report FDA Received Date11/18/2020
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 Age52 YR
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