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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNNLM
Medical Device Problem Codes Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Loss of Range of Motion (2032); Malunion of Bone (4529)
Date of Event 05/07/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
A ct scan was taken and showed that the left fossa component is not placed in its intended position.
 
Event or Problem Description
The patient's left mandibular component will be removed and revised due to the patient's malocclusion secondary to failed lefort and right sso surgery on the other side.
 
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Brand Name
PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
Common Device Name
LEFT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, LLC.
6059 king drive
ventura 93003 7607
MDR Report Key12329285
Report Number2031049-2021-00054
Device Sequence Number14141808
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLM0
UDI-Public+B004TYYNNNNLM0/$$3210101W46036
Combination Product (Y/N)N
Initial Reporter CountryDA
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/16/2021
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 Date01/01/2021
Device Model NumberTYY-NNNNLM
Device Catalogue NumberTYY-NNNNLM
Device Lot NumberW46036
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/03/2021
Initial Report FDA Received Date08/16/2021
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 Age68 YR
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