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

Model Number	TYY-NNNNLM
Medical Device Problem Codes	Positioning Failure (1158); Difficult to Insert (1316); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: LEFT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura 93003 7607
• MDR Report Key: 10826211
• Report Number: 2031049-2020-00089
• Device Sequence Number: 3267323
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNLM0
• UDI-Public: +B004TYYNNNNLM0/$$3220601W56028
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2020

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 17 YR