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 Perforation (2001)

Event Date 08/11/2016

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

After the initial osteotomy, doctor determined that the trajectory of dental implant sites #4,5, and 12 were off.Drill sites 4 and 5 perforated through the lingual plate.Drill sites 12 and 13 seem too close to each other.Although doctor did not detect any fit issue with the surgical guide, he suspect that the guide requirement to shave off the distal side of crown #11 by 1 mm may have caused the observed trajectory deviations.

Manufacturer Narrative

Device evaluation did not show any malfunction.The trajectory on the surgical guide followed the doctor's treatment plan.For this particular case, the surgical guide required shaving the distal side of crown #11 by 1 mm.However, doctor reported that he shaved off distal side of #6 and 11.Depending on the volume of the crown that was shaved off, the guide's fit may have been destabilized.In addition, knife edge bone ridge at implant site #4 and 5 could cause complications with drill slipping.

Event Description

After the initial osteotomy, doctor determined that the trajectory of dental implant sites #4, 5, and 12 were off.Drill sites 4 and 5 perforated through the lingual plate.Drill sites 12 and 13 seem too close to each other.Although doctor did not detect any fit issue with the surgical guide, he suspect that the guide requirement to shave off the distal side of crown #11 by 1 mm may have caused the observed trajectory deviations.

• 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: 5955130
• MDR Text Key: 54876982
• Report Number: 3008272529-2016-00027
• 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: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2016
• 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: 09/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2016
• 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: 86 YR