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

Model Number TYY-NNNNRM

Device Problem Difficult To Position (1467)

Patient Problem Joint Disorder (2373)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

There was approximately a 2mm difference in the occlusion planned by the surgeon and the one that he placed the patient into at the time of surgery.The surgeon placed a revision mandibular component on (b)(6) 2018 that took the altered occlusion into account.The cause of the operative difficulty in placing this right mandibular component is considered to be the surgeon's having placed the patient into a different occlusion at the time of surgery than he had established in his pre-operative planning.

Event Description

It was reported that the surgeon was not able to get the right mandibular component into acceptable position during the implant surgery.The mating fossa component was implanted without any complications.

• Brand Name: PATIENT-FITTED TMJ RIGHT MANDIBULAR COMPONENT
• Type of Device: RIGHT MANDIBULAR COMPONENT
• Manufacturer (Section D): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer (Section G): TMJ SOLUTIONS, INC.; 2233 knoll drive; ventura CA 93003 7398
• Manufacturer Contact: gregory rose ; 2233 knoll drive; ventura, CA 93003-7398 ; 8056503391
• MDR Report Key: 7551528
• MDR Text Key: 109480481
• Report Number: 2031049-2018-00004
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: B004TYYNNNNRM0
• UDI-Public: +B004TYYNNNNRM0/$$3191101W44148
• 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: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 11/01/2019
• Device Model Number: TYY-NNNNRM
• Device Catalogue Number: TYY-NNNNRM
• Device Lot Number: W44148
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2018
• 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: 45 YR