MAUDE Adverse Event Report: ANATOMAGE INC. INVIVODENTAL/TXSTUDIO; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Lot Number 5.3

Device Problem Application Program Version or Upgrade Problem (2881)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

The production records associated with the case were reviewed.A 6mm version of the doctor's desired implant type was placed in the case file.However, the 6 mm size of the implant was not present in the doctor's txstudio application implant library causing the application to display the implant in the closest available size of the same implant type (brand and model); in this case it was the 8mm size.When the doctor approved the treatment plan for guide fabrication, he had expected the implant to be 8 mm in length, as it appeared to be in his software.Note: the smaller implant is the more conservative option for avoiding undesired interaction with any potential nearby anatomical structures.It was determined that if a user had txstudio 5.4.1 or earlier, or invivodental 5.4.3 or earlier, and if their software library did not have the particular size of the implant present in the planning file, but did have the implant type (brand and model), the software would display the implant in the closest available size of the same implant type in the library without a warning message.Subsequent versions of invivodental and txstudio as of october 2015 have included warning messages for this scenario.The present complaint has been the only known instance in which a doctor reported a problem due to this issue.Therefore, this issue is considered an extremely rare occurrence and has been mitigated in recent releases of the software applications.In order to inform surgical guide customers of this possibility with older software versions, a notice was released on 08/16/2019 which advised surgical guide customers of this possibility and provided instructions on a workaround to mitigate the risk.As of 08/26/2019, anatomage is in the process of working with distributors to notify all txstudio and invivodental users.

Event Description

Before guided implant surgery was conducted, the doctor identified that the implant lengths between the reference chart provided with the guide and his treatment planning file did not match.The reference chart stated that the implant length was 6 mm but the planning file stated it was 8 mm.He also noticed that there was no 6 mm option available for his selected implant type.As the doctor was uncertain which implant length was considered during guide manufacture, he chose to free-hand the surgery.There have been no adverse events reported for the patient.Although the issue was first reported as a surgical guide compliant, the investigation identified that the cause was related to a discrepancy between invivodental/txstudio software versions which was used to create the treatment plan.Therefore, the suspect medical device section reflects the software product information.

• Brand Name: INVIVODENTAL/TXSTUDIO
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose CA 95110
• Manufacturer (Section G): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose CA 95110
• Manufacturer Contact: meera kler ; 303 almaden blvd.; suite 700; san jose, CA 95110
• MDR Report Key: 8942471
• MDR Text Key: 209802076
• Report Number: 3008272529-2019-00016
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 08/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: 5.3
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR