MAUDE Adverse Event Report: ANATOMAGE ANATOMAGE GUIDE; SURGICAL GUIDE

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 08/23/2016

Event Type  Injury  

Manufacturer Narrative

Since the device was returned 2 day prior to 30 day mdr time limit, evaluation of the surgical guide is in progress.

Event Description

Doctor experienced depth issues with site 14.After using second drill, doctor felt like he was drilling in bone more than he should.He followed the reference chart and used 22mm.After the second drill, he used a probe to check depth.He determined the osteotomy depth was much deeper than it should've been.He said from the crest of the bone to the apex of the osteotomy, the depth was about 15 or 16mm (even though his implant was 10mm length).To resolve the issue, he decreased the length for the last drills (only went 20mm rather than 22mm).Dr said he would've perforated the sinus but the patient had thick lining and determined the depth issue early on.

Manufacturer Narrative

Device evaluation did not show any malfunction.Surgery with a properly seated guide and the prescribed drill depths should have resulted in the correct depth.For this particular case, doctor reported that the tissue flap was performed for the implant site #12,13,and 14 whereas the device labeling indicate tissue flap requirement for only site #12 and 13.Without soft tissue support in the posterior implant site region, pressing down on the guide during drilling procedure may cause the guide to slightly bend and drill to go deeper than planned.

Event Description

Doctor experienced depth issues with site 14.After using second drill, doctor felt like he was drilling in bone more than he should.He followed the reference chart and used 22mm.After the second drill, he used a probe to check depth.He determined the osteotomy depth was much deeper than it should've been.He said from the crest of the bone to the apex of the osteotomy, the depth was about 15 or 16mm (even though his implant was 10mm length).To resolve the issue, he decreased the length for the last drills (only went 20mm rather than 22mm).Dr said he would've perforated the sinus but the patient had thick lining and determined the depth issue early on.

• 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: 5975130
• MDR Text Key: 55560746
• Report Number: 3008272529-2016-00028
• 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,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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: 09/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2016
• 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; Required Intervention
• Patient Age: 59 YR