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

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

Patient Problem No Code Available (3191)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

The device was not returned after several requests to send it to anatomage for evaluation.Therefore, the investigation primarily assessed the production records and processes as well as the doctor's treatment plan.The registration between the stone model and patient scan was confirmed to be acceptable per procedural guidelines.The trajectory of the materials were virtually examined and aligned with the doctor's treatment plan.The production record for the guide documents that it passed quality analysis with no adjustments necessary.The doctor's treatment plan was also reviewed to consider potential contributing factors.It shows that the implant was planned partially into the patient's buccal plate, and only 0.3 mm away from the patient's nasopalatine canal.Although the doctor did not provide additional details on the reported issue, it is likely that the buccal plate, and possibly the nasopalatine canal, were pierced during surgery.Therefore, the most likely cause of this adverse event was the doctor's treatment plan which had placed the implant on or near critical structures which would necessitate intervention and grafts.

Event Description

The doctor used the surgical guide to perform drilling, however, the trajectory appeared to be off from the treatment plan.The doctor decided to abort surgery and graft the patient.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose CA 95110
• Manufacturer (Section G): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose CA 95110
• Manufacturer Contact: meera kler ; 303 almaden blvd.; suite 700; san jose, CA 95110
• MDR Report Key: 8672312
• MDR Text Key: 147158192
• Report Number: 3008272529-2019-00012
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2019
• Initial Date FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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: 82 YR