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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS

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TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS TMJ BILATERAL IMPLANTS; PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS Back to Search Results
Catalog Number CHG020
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Ankylosis (4527)
Event Date 02/20/2024
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
 
Event Description
It was reported there was a revision surgery to remove the right side tmj implant due to heterotopic bone.
 
Manufacturer Narrative
Update: h6.The reported event has been confirmed, as the surgeon provided images clearly showing the removal of the right tmj device.Additionally, the surgeon has initiated the order for revision devices.The patient presented to the surgeon due to severe right tmj pain and limited mouth opening.A ct scan was taken, which showed dystrophic bone growth around the implants and fossa components bilaterally.A month later, the surgeon performed a right tmj osteoplasty removal and replanting of the prosthesis.However, the patient experienced complicated postoperative symptoms, including pain and limited opening.A month later, purulence was noted from the incision site, with gradual improvement and minimal symptom relief.The patient presented again six months later due to recurrent severe right tmj pain on (b)(6) 2023.Consequently, the surgeon removed the right tmj prosthesis on (b)(6) 2023 and placed a stock condyle.However, the patient continued to experience pain and deviation, prompting the surgeon to plan a revision of the right tmj devices.Revision devices are being designed, manufactured, and shipped under id#2401081041.Based on the investigation, there is no indication of an incorrectly working product or any design, material, or manufacturing-related issue.
 
Event Description
It was reported there was a revision surgery to remove the right side tmj implant due to heterotopic bone.
 
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Brand Name
TMJ BILATERAL IMPLANTS
Type of Device
PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
Manufacturer (Section D)
TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
6059 king drive
ventura 93003
Manufacturer (Section G)
TMJ SOLUTIONS, LLC DBA TMJ CONCEPTS
6059 king drive
ventura 93003
Manufacturer Contact
rylee koole
6059 king drive
ventura 93003
8056503391
MDR Report Key18932883
MDR Text Key338023744
Report Number0002031049-2024-00024
Device Sequence Number1
Product Code LZD
UDI-Device Identifier07613327626575
UDI-Public07613327626575
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P980052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/19/2024
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
Device Operator Health Professional
Device Catalogue NumberCHG020
Device Lot NumberT16-0896
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/20/2024
Initial Date FDA Received03/19/2024
Supplement Dates Manufacturer Received02/20/2024
Supplement Dates FDA Received07/19/2024
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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