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

Model Number TYY-NNNNLM

Device Problems Positioning Failure (1158); Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  Injury  

Manufacturer Narrative

The surgeon planned to excise the scar tissue and heterotopic bone bilaterally, advance the patient's mandible forward, and place revision mandibular components.At the time of surgery, the surgeon debrided the heterotopic bone and removed the scar tissue but was unable to advance the patient's mandible forward due to the patient's severe fibrosis.The surgeon could not place the revision tmj mandibular devices and elected to re-implant the previous components.

Event Description

The surgeon was unable to place these revisions tmj mandibular devices due to the patient's severe fibrosis and scarring of the soft tissue envelope around bilateral tmj implants.

• 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: 10826211
• MDR Text Key: 215889631
• Report Number: 2031049-2020-00089
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLM0
• UDI-Public: +B004TYYNNNNLM0/$$3220601W56028
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: TYY-NNNNLM
• Device Catalogue Number: TYY-NNNNLM
• Device Lot Number: W56028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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: 17 YR