MAUDE Adverse Event Report: ANATOMAGE ANATOMAGE GUIDE; SURGICAL GUIDE

Device Problems Device-Device Incompatibility (2919); Compatibility Problem (2960)

Patient Problem Perforation (2001)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

This incompatibility issue is due to miscommunication about which instrumentation the doctor owned.

Event Description

Due to compatibility issue with the handles and the sleeves, doctor could not use the surgical guide for dental implant surgery.Doctor freehanded the surgery but was not successful.Implant 28 failed; drill slipped out the lingual.Other implants are not parallel as he wanted.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE; 303 almaden blvd; suite 700; san jose CA 95110
• Manufacturer (Section G): ANATOMAGE; 303 almaden blvd; suite 700; san jose CA 95110
• Manufacturer Contact: phyo soe ; 303 almaden blvd; suite 700; san jose, CA 95110 ; 4088851474
• MDR Report Key: 6836697
• MDR Text Key: 84301833
• Report Number: 3008272529-2017-00022
• 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: Dentist
• Type of Report: Initial
• Report Date: 07/19/2017

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: Dentist
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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: 85 YR
• Patient Weight: 59