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

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 06/22/2013

Event Type  Injury  

Event Description

The doctor received the anatomage guide and noticed that the guide did not fit over the stone model.The guide also had fit problems in the pt's mouth as it was not well seated and rocking from side to side.However, the doctor used the guide anyway and when he drilled with the 2.0mm drill it drilled too lingual.He bone grafted and sutured the area.Local anesthesia was administered for the procedure.

Manufacturer Narrative

Method: guide fit reviewed by comparing stone model cbct scan used for production to stone model optical scan.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; san jose CA
• Manufacturer Contact: shirley lee ; 111 n market st; ste 500; san jose, CA 95113 ; 4088851474
• MDR Report Key: 4008117
• MDR Text Key: 15364143
• Report Number: 3008272529-2014-00003
• 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: 06/25/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/05/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2013
• Initial Date FDA Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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: 49 YR
• Patient Weight: 68