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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

Event Type  Injury  

Manufacturer Narrative

The surgeon reported that the mandibular component was functioning fine and plans to place revision devices later.This event is related to mdr 2031049-2020-00084).

Event Description

The surgeon elected to remove the left mandibular implant at the same time he removed the mating fractured left fossa component.

• 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 CA 93003 7606
• Manufacturer Contact: lorena lundeen ; 6059 king drive; ventura, CA 93003-7607 ; 8056503391
• MDR Report Key: 10977608
• MDR Text Key: 220493588
• Report Number: 2031049-2020-00104
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLM0
• UDI-Public: +B004TYYNNNNLM0/$$3210701W51878$
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: TYY-NNNNLM
• Device Catalogue Number: TYY-NNNNLM
• Device Lot Number: W51878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR