MAUDE Adverse Event Report: TMJ SOLUTIONS, LLC. PATIENT-FITTED TMJ LEFT FOSSA COMPONENT

Model Number TYY-NNNNLF

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

Patient Problems Joint Dislocation (2374); Fibrosis (3167)

Event Date 06/10/2021

Event Type  Injury  

Manufacturer Narrative

The patient received left tmj devices in 2018.The surgeon reported that the patient dislocated originally due to overstretching his jaw.In (b)(6) 2020, the patient was intubated and dislocated again.The surgeon removed and replaced the fossa component.

Event Description

The patient's left fossa component was removed and replaced with a revised component due to dislocation.

• Brand Name: PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
• Type of Device: LEFT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, LLC.; 6059 king drive; ventura 93003 7607
• Manufacturer (Section G): TMJ SOLUTIONS, LLC.; 6059 king drive; ventura 93003 7606
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura 93003-7607 ; 8056503391
• MDR Report Key: 11996703
• MDR Text Key: 256115474
• Report Number: 2031049-2021-00040
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLF0
• UDI-Public: +B004TYYNNNNLF0/$$3191001W43310
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: TYY-NNNNLF
• Device Catalogue Number: TYY-NNNNLF
• Device Lot Number: W43310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/10/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2018
• 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: 71 YR