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

Model Number TNN-NNNLF

Device Problem Break (1069)

Patient Problem Joint Disorder (2373)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

This patient received bilateral tmj implants in (b)(6) 2008.The surgeon reported that the left fossa component was fractured and that he was planning on revising it.The production documentation was reviewed and no nonconformance was identified.The device remains implanted, and the investigation is ongoing.A follow-up mdr will be submitted once the investigation has been completed.

Event Description

The patient's left fossa component is suspected of being fractured.

Manufacturer Narrative

The surgeon removed the fractured component and placed a revision fossa in a single-stage surgery.

Event Description

The surgeon removed the patient's fractural fossa component.

• Brand Name: PATIENT-FITTED TMJ LEFT FOSSA COMPONENT
• Type of Device: LEFT FOSSA COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura, ca CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura, ca CA 93003 7398
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, ca, CA 93003-7398 ; 8056503391
• MDR Report Key: 8242635
• MDR Text Key: 132978878
• Report Number: 2031049-2019-00002
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980052
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2010
• Device Model Number: TNN-NNNLF
• Device Catalogue Number: TNN-NNNLF
• Device Lot Number: W13761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2008
• 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: 46 YR