MAUDE Adverse Event Report: ANATOMAGE ANATOMAGE GUIDE; SURGICAL GUIDE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation revealed that a consultant accidentally changed the implant's length while changing the implant's diameter to appropriate size.

Event Description

Doctor reviewed the device instruction for use and realized that the surgical guide was set-up for a longer implant at site #18.Had he not caught this discrepancy, he would have drilled 3mm deeper into patient's mandible bone.

• 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: 7053639
• MDR Text Key: 93301952
• Report Number: 3008272529-2017-00034
• 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: 10/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2017
• 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 Age: 58 YR