MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT; RIGHT FOSSA COMPONENT

Model Number TYY-NNNRF

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Disorder (2373)

Event Date 09/01/2020

Event Type  Injury  

Manufacturer Narrative

The patient's right fossa component was removed along with the previously revised mandibular component from another manufacturer (see mfr # 2031049-2020-00080).The patient's surgeon plans to place revision fossa and mandibular devices in a few months.

Event Description

The patient's right fossa component was removed due to pain and revised surgery.

• Brand Name: PATIENT-FITTED TMJ RIGHT FOSSA COMPONENT
• Type of Device: RIGHT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7606
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura 93003-7607 ; 8056503391
• MDR Report Key: 10505547
• MDR Text Key: 206105349
• Report Number: 2031049-2020-00081
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRF0
• UDI-Public: +B004TYYNNNNRF0/$$3150701W26671
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: TYY-NNNRF
• Device Catalogue Number: TYY-NNNRF
• Device Lot Number: W26671
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR