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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT; RIGHT MANDIBULAR COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT; RIGHT MANDIBULAR COMPONENT Back to Search Results
Model Number TYY-NNNNRM
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 08/12/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
It was reported that the patient's right tmj implants were removed due to infection.The surgeon plans to replace the implant after the infection has resolved.Multiple mdr's were submitted for this event.Please reference the report # 2031049-2020-00077.
 
Event or Problem Description
The patient's right tmj devices were removed due to infection.
 
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Brand Name
PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
Common Device Name
RIGHT MANDIBULAR COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura,
MDR Report Key10451703
Report Number2031049-2020-00078
Device Sequence Number11730256
Product Code LZD
UDI-Device IdentifierB004TYYNNNNRM0
UDI-Public+B004TYYNNNNRM0/$$3220101W54199/
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 Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 08/25/2020
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 Date01/01/2022
Device Model NumberTYY-NNNNRM
Device Catalogue NumberTYY-NNNNRM
Device Lot NumberW54199
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/18/2020
Initial Report FDA Received Date08/25/2020
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 Required Intervention;
Patient Age43 YR
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