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

Model Number TYY-NNNLF

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Joint Disorder (2373)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

An image was taken and showed two bone screws in the patient's left fossa component were loose and backing out.The surgeon removed the fossa component and placed a revision device.

Event Description

The patient's left fossa component was removed and replaced with a revision device because of loose bone screws.

• 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
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 6059 king drive; ventura,
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, ; 6503391
• MDR Report Key: 10317613
• MDR Text Key: 200239354
• Report Number: 2031049-2020-00058
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLF0
• UDI-Public: +B004TYYNNNNLF0/$$3160101W28422
• 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: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: TYY-NNNLF
• Device Catalogue Number: TYY-NNNLF
• Device Lot Number: W28422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 77 YR