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 06/09/2020

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, the guide mold's trajectory aligns with the final treatment plan, and no issues were noted during the guide's fabrication.Additionally, all production processes were found to have been properly followed.The cause of the trajectory deviation could not be determined.The discrepancy between the implant's planned and final locations may have been due to the width of the bone ridge being exaggerated due to ghosting in the patient scan.

Event Description

The doctor used the guide for implant surgery.After placing the implant, the doctor was able to see the implant through the patient's gingiva.She then took a post-op ct scan and realized that the implant was positioned in the buccal plate.The implant was left in and the area was grafted.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose, ca
• Manufacturer (Section G): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose, ca
• Manufacturer Contact: meera kler ; 303 almaden blvd.; suite 700; san jose, ca
• MDR Report Key: 10221858
• MDR Text Key: 201225595
• Report Number: 3008272529-2020-00004
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 06/23/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• 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: 50 YR