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

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

Patient Problems Failure of Implant (1924); Inadequate Osseointegration (2646); Tissue Breakdown (2681)

Event Date 04/17/2021

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that all production processes were properly followed, and the guide was fabricated properly as per the doctor's approved final plan.The implant failures were likely caused by the patient having poor-quality bone or insufficient natural bone at the sites.Further analysis will be performed if the surgical guide is returned to anatomage.

Event Description

The guide was used for implant surgery to successfully place two implants (#7 and #10) on (b)(6) 2021.On (b)(6) 2021, the patient went back to the doctor's office to remove stitches and take a post-op scan, which looked great according to the doctor.However, on (b)(6) 2021, the patient informed the doctor that implant #7 fell out.On (b)(6) 2021, the patient went back to the doctor's office and implant #10 fell out when the doctor "wiggled it".The doctor also stated that the patient's bone looked horrible and probably had low density, which she believes should have been caught during case planning.

• 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: 11823179
• MDR Text Key: 250799993
• Report Number: 3008272529-2021-00012
• 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: 05/13/2021

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2021
• 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: 62 YR