MAUDE Adverse Event Report: ANATOMAGE INC. ANATOMAGE GUIDE; SURGICAL GUIDE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 06/24/2019

Event Type  Injury  

Manufacturer Narrative

The investigation determined that there were no device malfunctions.Production records indicate that registration between the stone model and patient scan was acceptable.The guide initially passed its quality analysis prior to shipment, confirming that the trajectories aligned with the dental model.The returned guide was determined to seat well on the dental model with stable sleeves.The trajectory analysis determined that the trajectory aligned well with the treatment plan and the deviation was within the standard tolerance of <0.5 mm.The treatment plan for this case was reviewed.The placement of the implants was done during a case planning session between the doctor and one of our surgical guide consultants via (b)(6).The consultant placed the implants based on the doctor's input, which the doctor was able to see and approve in real time.The treatment plan with the implant trajectories seen in the attached report was approved by the doctor prior to guide fabrication.As the trajectories were confirmed to align with the treatment plan, the reported observations during surgery by the doctor may have conflicted with her initial perception during case planning.

Event Description

The doctor successfully seated the guide in the patient's mouth and began surgery with the 2.2 mm drill for all sites.The doctor attempted to use the 2.8 mm drill but stopped after she observed that the trajectories looked off for all sites.She claimed that site 4 appeared to be too buccal, site 6 was too angled, and that sites 4 and 5 looked closer than planned.No implants were placed and all sites were grafted.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• 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: 8843067
• MDR Text Key: 152699842
• Report Number: 3008272529-2019-00013
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/02/2019

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
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2019
• 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: 69 YR