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 04/09/2019

Event Type  Injury  

Manufacturer Narrative

The investigation determined that there were no device malfunctions.A partial guide was created as the doctor had submitted a partial model.The partial guide registration was reviewed and determined to be acceptable per procedural guidelines.The guide passed its quality analysis with no adjustments necessary.As the guide was not returned after several requests, manufacturing analysis is limited to production records and processes which were determined to be acceptable.The treatment plan was reviewed which shows that the implant site surface appeared to be significantly less dense than the area 7 mm deeper.The area which is deeper and denser appears to form a point.The drill may have hit the edge of this point, potentially causing it to slip and veer either mesial or distal and causing the trajectory to deviate from the treatment plan.Therefore, the most likely cause of this issue is drill slippage due to challenging patient morphology.

Event Description

The doctor used the surgical guide to perform drilling, however, the trajectory appeared to be off from the treatment plan.The doctor decided to abort surgery and graft the patient.

• 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: 8672311
• MDR Text Key: 147166501
• Report Number: 3008272529-2019-00010
• 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: 05/06/2019

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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 Age: 75 YR