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

Model Number TYY-NNNNLM

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Joint Dislocation (2374)

Event Date 02/10/2020

Event Type  Injury  

Manufacturer Narrative

Six months after receiving bilateral tmj implants, the patient dislocated on the left side.The surgeon repositioned the mandibular component so that the condylar head would articulate in its intended design position in the fossa bearing.No additional consequences were reported.

Event Description

The patient's left tmj devices dislocated.The surgeon repositioned the mandibular component.

• Brand Name: PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
• Type of Device: LEFT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura, ca
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura, ca
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, ca ; 6503391
• MDR Report Key: 9753198
• MDR Text Key: 185116099
• Report Number: 2031049-2020-00009
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLM0
• UDI-Public: +B004TYYNNNNLM0/$$3210301W50140
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Model Number: TYY-NNNNLM
• Device Catalogue Number: TYY-NNNNLM
• Device Lot Number: W50140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2019
• 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): Other; Required Intervention
• Patient Age: 66 YR