Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT; LEFT MANDIBULAR COMPONENT
  • 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, INC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT; LEFT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNNLM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Joint Dislocation (2374)
Date of Event 02/16/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The surgeon reported that the device was dislocated due to heterotopic bone, and he removed it.The surgeon elected to remove the device.
 
Event or Problem Description
The patient's left tmj mandibular component was removed due to recurring dislocation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11341032
Report Number2031049-2021-00011
Device Sequence Number2671876
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLM0
UDI-Public+B004TYYNNNNLM0/$$3211001W52912
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/17/2021
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 Date10/01/2021
Device Model NumberTYY-NNNNLM
Device Catalogue NumberTYY-NNNNLM
Device Lot NumberW52912
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/10/2021
Initial Report FDA Received Date02/17/2021
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 Age12 YR
-
-