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

Model Number	TYY-NNNNRM
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Code	Joint Disorder (2373)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgeon reported that he was unable to place the mandibular implants after performing a lefort on the patient.The surgeon reported that the patient did not have a good occlusion during the planning stages, and could not adequately open the patient's mouth for taking dental impressions.The surgeon placed spacers bilaterally and staged the patient.Revision devices were designed and manufactured, and placed at a later date.Multiple mdr's were filed for this event (see associated report 2031049-2020-00052).
Event or Problem Description
The surgeon was unable to place the bilateral mandibular components.

• Brand Name: PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
• Common Device Name: RIGHT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 6059 king drive; ventura,
• MDR Report Key: 10304432
• Report Number: 2031049-2020-00053
• Device Sequence Number: 14169220
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRM0
• UDI-Public: +B004TYYNNNNRM0/$$3190501W40775
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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: 05/01/2019
• Device Model Number: TYY-NNNNRM
• Device Catalogue Number: TYY-NNNNRM
• Device Lot Number: W40775
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2020
• Initial Report FDA Received Date: 07/21/2020
• 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: 15 YR