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

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 08/21/2013

Event Type  Injury  

Manufacturer Narrative

Method: analyzed stone model overlay on patient scan.

Event Description

The doctor found that the guide seated okay on the patient, but the guide collar was too facial, giving an undesirable trajectory.2/3 of the implant on apical end was visual through the palatal side.The doctor removed the implant and bone grafted.He then re-did the surgery.Note: the guide was altered by the doctor who sectioned the guide at tooth 11.

• 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 95113-0000 ; 4088851474
• MDR Report Key: 4028066
• MDR Text Key: 19375016
• Report Number: 3008272529-2014-00008
• 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: 08/21/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2014
• 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: 08/23/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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: 68 YR
• Patient Weight: 75