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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT Back to Search Results
Model Number TYY-NNNNM
Medical Device Problem Codes Positioning Failure (1158); Difficult to Insert (1316)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/29/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This patient was scheduled to receive bilateral tmj devices on (b)(6) 2020.At the time of the surgery, the surgeon reported that he could not replicate his operative plan due to the patient's soft tissue.The surgeon placed spacers bilaterally and plans to have revision devices designed and manufactured to accommodate the achieved occlusion.
 
Event or Problem Description
It was reported that the surgeon was unable implant these bilateral tmj devices.
 
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Brand Name
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Common Device Name
TEMPOROMANDIBULAR JOINT IMPLANT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura CA 93003 7607
MDR Report Key10652928
Report Number2031049-2020-00085
Device Sequence Number16828715
Product Code LZD
UDI-Device IdentifierB004TYYNNNNM0
UDI-Public+B004TYYNNNNM0/$$7W54697
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
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 Date05/01/2022
Device Model NumberTYY-NNNNM
Device Catalogue NumberTYY-NNNNM
Device Lot NumberW54697
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/29/2020
Initial Report FDA Received Date10/08/2020
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 Other; Required Intervention;
Patient Age26 YR
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