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

Model Number TYY-NNNNRM

Device Problem Osseointegration Problem (3003)

Patient Problem Joint Disorder (2373)

Event Date 03/16/2017

Event Type  Injury  

Manufacturer Narrative

The patient received bilateral implants in 2016.Several months later, she presented to her surgeon with malocclusion.A new ct scan showed that the right mandibular component with the inferior six bone screws were starting to pull out.The surgeon decided to place a revised along with the right mandibular component on (b)(6) 2017.

Event Description

The patient's right tmj mandibular component was revised due to component looseing secondary to malocclusion.

• Brand Name: PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
• Type of Device: RIGHT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura,
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura,
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, ; 6503391
• MDR Report Key: 10187128
• MDR Text Key: 196256593
• Report Number: 2031049-2020-00030
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRM0
• UDI-Public: +B004TYYNNNNRM0/$$3180101W36247
• 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: 06/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Model Number: TYY-NNNNRM
• Device Catalogue Number: TYY-NNNNRM
• Device Lot Number: W36247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 06/23/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2016
• 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: 65 YR