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 03/04/2020

Event Type  Injury  

Manufacturer Narrative

The guide mold's trajectory aligns with the treatment plan, and no issues were noted during the guide's fabrication.Additionally, all production processes were found to have been properly followed.The limited bone at the at the implant site, and the implant collar's subsequent proximity to the lingual plate, was likely the greatest contributing factor to the issue.This, combined with a slightly deviated guide trajectory, and/or excessive lateral force applied during surgery, likely led to the exposed collar.

Event Description

The doctor used the guide for implant surgery.The guide was used to place an implant at site #19 on (b)(6) 2020.After surgery, the doctor took an x-ray and observed that the trajectory was slightly off, and the collar was exposed on the lingual side.The implant was left in but ultimately failed, and was removed some time in late (b)(6) 2020.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 3350 scott blvd. bldg 29; santa clara, ca
• Manufacturer (Section G): ANATOMAGE INC.; 3350 scott blvd bldg 29; santa clara, ca
• Manufacturer Contact: meera kler ; 3350 scott blvd. bldg 29; santa clara, ca ; 8851474
• MDR Report Key: 10578347
• MDR Text Key: 208307602
• Report Number: 3008272529-2020-00009
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: 39 YR