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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Injury (2348)

Event Date 08/20/2020

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that the trajectory of the guide aligns with the final plan.Additionally, all production processes were found to have been properly followed.The trajectory deviation may have been caused by an inaccurate patient scan, and/or drill slippage occurring due to the change in morphology caused by a tooth extraction.

Event Description

The doctor used the guide for implant surgery and placed implants at sites #3, #4, and #13.Three weeks after surgery, the patient went back to the doctor's office with some swelling around site #13.The doctor prescribed antibiotics, but after the fourth week of swelling, the doctor decided to take a new ct scan.From the scan, the doctor observed that #13 had perforated the buccal plate.The implant was then removed and the site was grafted.No issues were reported with implants #3 and #4.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 3350 scott blvd. bldg 29; santa clara CA 95054
• Manufacturer (Section G): ANATOMAGE INC.; 3350 scott blvd bldg 29; santa clara CA 95054
• Manufacturer Contact: meera kler ; 3350 scott blvd. bldg 29; santa clara, CA 95054 ; 4088851474
• MDR Report Key: 10627337
• MDR Text Key: 209816712
• Report Number: 3008272529-2020-00011
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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