MAUDE Adverse Event Report: ANATOMAGE ANATOMAGE GUIDE; SURGICAL GUIDE

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

After reviewing the case information and evaluating the device, we suspect that the following factors may have contributed to the implant placement issue resulting from using the surgical guide: user error: review of the analog model showed that there are distinguishable differences between implant placement in analog model and the treatment plan.The position of the implant analogs in the analog model does not match up with the position of the virtual implants in the treatment plan.This suggests that the doctor's "expection" of the implant placement may be different from the actual treatment plan he uploaded.Failure to follow instruction for use: doctor reported that tissue punch were perform for all the implant sites.However, the guide required tissue flap implant site #12.Without the tissue flap, the guide will not be fully seated in the patient's mouth.Soft tissue will be pushing the guide up and the trajectory will be altered as a result.Manufacturing deficiency: evaluation of the guide revealed that the trajectory for implant site #12 and #13 matches up with the treatment plan but site #14 was found to be more mesio-lingual.Corrective action will be taken to improve the guide fabrication qa process.

Event Description

Doctor determined that implant placement at site #13 using surgical guide was too buccal.He also think implant #12 may be also off lingually.

• 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: 6363232
• MDR Text Key: 68525711
• Report Number: 3008272529-2017-00006
• 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: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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): Other
• Patient Age: 79 YR