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

Model Number TYY-NNNNLM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthralgia (2355); Implant Pain (4561)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

The patient has a long history of tmj pain and dysfunction.The surgeon previously performed exploratory surgery and removed synovial entrapment (mfr.#2031049-2020-00004).However, the patient's pain persisted.The surgeon elected to remove the left tmj implants, and reported that the devices did not exhibit any hardware failure.Multiple mdr's were submitted for this event ( reference 201349-2020-00092).

Event Description

The patient's left tmj devices were removed due to pain.

• Brand Name: PATIENT-FITTED TMJ LEFT MANDIBULAR COMPONENT
• Type of Device: LEFT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7606
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura 93003-7607 ; 8056503391
• MDR Report Key: 10833751
• MDR Text Key: 216098133
• Report Number: 2031049-2020-00093
• Device Sequence Number: 1
• Product Code: LZD
• 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: 11/12/2020

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: 11/01/2020
• Device Model Number: TYY-NNNNLM
• Device Catalogue Number: TYY-NNNNLM
• Device Lot Number: W48085
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2020
• Initial Date FDA Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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: 65 YR