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

Model Number TYY-NNNNM

Device Problem Installation-Related Problem (2965)

Patient Problem Joint Disorder (2373)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

This patient was scheduled to receive left tmj implants on (b)(6) 2019.It was reported that the surgeon was unable to fully replicate the planned resection and bony contouring needed in order to place the implants due to the extensive heterotopic bone along the zygomatic arch of the patient's fossa.A new ct scan of the patient will be taken and new joints will be designed and produced to match the resection and contouring that was achieved.

Event Description

The surgeon was unable to place the left unilateral tmj implants.

• Brand Name: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS
• Type of Device: TEMPOROMANDIBULAR JOINT IMPLANT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer Contact: gregory rose ; 2233 knoll drive; ventura, CA 93003-7398 ; 8056503391
• MDR Report Key: 8812385
• MDR Text Key: 151753883
• Report Number: 2031049-2019-00027
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNM0
• UDI-Public: +B004TYYNNNNM0/$$7W49356
• 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: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: TYY-NNNNM
• Device Catalogue Number: TYY-NNNNM
• Device Lot Number: W49356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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): Required Intervention
• Patient Age: 73 YR