MAUDE Adverse Event Report: TMJ SOLUTIONS, INC. PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS; TEMPOROMANDIBULAR JOINT IMPLANT

Model Number TYY-NNNNM

Device Problems Positioning Failure (1158); Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

This patient was scheduled to receive bilateral implants on (b)(6) 2020.At the time of this surgery, this surgeon stated that he was not able to advance the patient's mandible as planned due to his inability to mobilize the patient's soft tissue.The surgeon elected to place bilateral stock tmj devices from another manufacturer.

Event Description

It was reported that the surgeon was not able to get the tmj implant components into acceptable position during the implant surgery and chose to not implant the devices.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Type of Device: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura CA 93003 7607
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura CA 93003 7606
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, CA 93003-7607 ; 8056503391
• MDR Report Key: 10610843
• MDR Text Key: 209347206
• Report Number: 2031049-2020-00083
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W52593$
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: TYY-NNNNM
• Device Catalogue Number: TYY-NNNNM
• Device Lot Number: W52593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: 12 YR