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 12/28/2019

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, the guide mold's trajectory aligns with the treatment plan, and no issues were noted during the guide's fabrication.Additionally, all production processes were found to have been properly followed.The cause of the trajectory deviation could not be determined.Further testing will be conducted if the surgical guide is returned.

Event Description

The doctor used the guide for implant surgery.The drill penetrated the patient's lingual plate at site #8.Site #8 was grafted and sutured.Implant #9 was placed successfully.The incident occurred on (b)(6) 2019; however, the doctor did not report it to anatomage until (b)(6) 2020.

• 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: 9838742
• MDR Text Key: 188815799
• Report Number: 3008272529-2020-00003
• 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: 03/16/2020

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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: 50 YR