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

Device Problems Product Quality Problem (1506); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  Injury  

Event Description

The doctor reported that when he put the guide on the pt the fit was slightly tight but fine.Doctor laid a flap at both sites #13 and #14.He drilled the pilot drill, took a pa, and noticed #13 was too mesial and was close to the root of #12.If the doctor had continued with the drilling sequence, he may have hit the root of #12.The doctor reported that he free-handed the rest of the surgery and moved both implants more distal resulting in successful implant placement.

• 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: 5200627
• MDR Text Key: 30457004
• Report Number: 3008272529-2015-00021
• 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: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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: 69 YR
• Patient Weight: 59