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

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

Patient Problem Injury (2348)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

While no direct cause of the trajectory deviation could be determined, it may have been related to the material discrepancy that was discovered during the registration process.The double image that was present in the patient scan could have caused the arch to be misrepresented, subsequently causing the implant to be placed at the incorrect location during planning.This material discrepancy was reported to the doctor, who chose to proceed with the current materials.Additional testing will be conducted if the surgical guide is returned.See attached to reference the supporting analysis for additional details.(b)(4).

Event Description

The doctor used the guide for implant surgery.Implants were placed at sites #2, 3, 10, 12, and 14.The doctor then took a post-operative scan, from which he observed that implant #10 had perforated the buccal plate.The implant was removed and the area was grafted.All other implants were successfully placed.No seating issues were observed.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose, ca
• Manufacturer (Section G): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose, ca
• Manufacturer Contact: meera kler ; 303 almaden blvd.; suite 700; san jose, ca
• MDR Report Key: 10341187
• MDR Text Key: 202517171
• Report Number: 3008272529-2020-00007
• 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
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2020
• 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: 57 YR