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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
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TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT Back to Search Results
Model Number TYY-NNNNLF
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Codes Failure of Implant (1924); Implant Pain (4561)
Date of Event 10/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The surgeon reported that this patient had developed a significant amount of heterotopic bone between the planning and implant surgery stages.The surgeon stated that he removed too much bone, which leads to the device not being properly supported.The surgeons plan to have a new fossa component designed and manufactured.
 
Event or Problem Description
The patient's left fossa component was removed due to fractured.
 
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Brand Name
PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
Common Device Name
LEFT FOSSA COMPONENT
Manufacturer (Section D)
TMJ SOLUTIONS, INC.
6059 king drive
ventura 93003 7607
MDR Report Key10646363
Report Number2031049-2020-00084
Device Sequence Number19517412
Product Code LZD
UDI-Device IdentifierB004TYYNNNNLF0
UDI-Public+B004TYYNNNNLF0/$$3210701W51877
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
P980052
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
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) 10/07/2020
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? Yes
Operator of Device Health Professional
Device Expiration Date07/01/2021
Device Model NumberTYY-NNNNLF
Device Catalogue NumberTYY-NNNNLF
Device Lot NumberW51877
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/01/2020
Initial Report FDA Received Date10/07/2020
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;
Patient Age43 YR
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