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 Malposition of Device (2616)
Health Effect - Clinical Code Joint Dislocation (2374)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
An x-ray was taken, and it showed that the fossa components were placed anterior relative to the posterior border.No additional information is available at this time.Multiple mdr's were submitted for this event(2031049-2020-00096).
 
Event or Problem Description
The patient's left tmj mandibular component is dislocated.
 
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 Key10901485
Report Number2031049-2020-00095
Device Sequence Number1283287
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLM0
UDI-Public+B004TYYNNNNLM0/$$3211201W52888$
Combination Product (Y/N)N
Initial Reporter StateCA
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
Report Date (Section B) 11/24/2020
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 Date12/01/2021
Device Model NumberTYY-NNNNLM
Device Catalogue NumberTYY-NNNNLM
Device Lot NumberW52888
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/05/2020
Initial Report FDA Received Date11/25/2020
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;
-
-