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

Device Problem Material Torqued (2980)

Patient Problem No Code Available (3191)

Event Date 05/16/2014

Event Type  Injury  

Event Description

The dentist claimed that while using anatomage guide, the implant trajectory was too buccal.The dentist took out the implant and did a bone graft.Local anesthesia was administered for the procedure.The dentist will wait 3-4 months for the bone to heal before re-doing the surgery to place the implant.

Manufacturer Narrative

Type of evaluation performed: the guide was seated on a printed dental model with anatomage insert.Gauge pin was then seated in the insert to visualize the trajectory of the guide.The assembly from step 1 is optical scanned and superimposed onto the treatment plan.Trajectory of the gauge pin was measure against the implant positioned in the treatment plant.Axial center to center distance are taken at the implant's crest and apex to determine whether the trajectory is off.

• Brand Name: ANATOMAGE GUID
• 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: 4017579
• MDR Text Key: 4876573
• Report Number: 3008272529-2014-00001
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• 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: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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: 51 YR