• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 03/05/2024
Event Type  Injury  
Manufacturer Narrative
Device is not available for evaluation.If additional information is received it will be reported on a supplemental report.H3 other text : implanted.
 
Event Description
It was reported the surgeon will perform a revision surgery to revise and replace the tmj implant.
 
Manufacturer Narrative
Update: h6: the reported event has been confirmed.As the surgeon, provided images clearly showing heterotopic bone formation around the joints.Which medical experts confirmed.This patient received, a bilateral set of tmj implants on (b)(6) 2009.Since several years ago, the patient has had a limited opening of about 15mm.And has experienced significant pain.The patient previously had an opening mouth around 30mm.There is no evidence of infection or material sensitivity.The surgeon plans to replace both joints.He will aggressively debride, during the surgery to ensure a good opening intraoperatively.A stryker clinical consultant reviewed, the new patient imaging and confirmed, the existence of heterotopic bone.Which aligns with the patient's history.The pain results, from the patient attempting to open wide against the developing bone formation.A typical symptom of heterotopic ossification development.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, the surgeon will perform a revision surgery to revise and replace the tmj implant.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18998493
MDR Text Key338876096
Report Number0002031049-2024-00030
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 NumberT09-179
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/28/2024
Supplement Dates Manufacturer Received03/05/2024
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;
-
-