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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 Fracture (1260)
Patient Problems Failure of Implant (1924); Pain (1994); Ankylosis (4527)
Event Date 04/02/2024
Event Type  Injury  
Event Description
It was reported that it was discovered post operative, the right fossa component is broken.The surgeon will perform a revision surgery to remove the tmj devices.
 
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.
 
Manufacturer Narrative
The event has been confirmed as the surgeon provided imaging showing the right fossa component was fractured.The surgeon plans to remove and revise the right fossa component.Based on the investigation, there is no indication of a malfunctioning product or any issues related to design, material, or manufacturing.
 
Event Description
It was reported that it was discovered post operative, the right fossa component is broken.The surgeon will perform a revision surgery to remove the tmj devices.
 
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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 Key19163696
MDR Text Key340825424
Report Number0002031049-2024-00041
Device Sequence Number1
Product Code LZD
UDI-Device Identifier07613327626575
UDI-Public07613327626575
Combination Product (y/n)N
Reporter Country CodeLH
PMA/PMN Number
P980052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/14/2024
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? Yes
Device Operator Health Professional
Device Catalogue NumberCHG020
Device Lot NumberT19-0323
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/02/2024
Initial Date FDA Received04/23/2024
Supplement Dates Manufacturer Received04/02/2024
Supplement Dates FDA Received08/14/2024
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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