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

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

Patient Problem Perforation (2001)

Event Date 10/21/2020

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that the trajectory of the returned guide aligns with the final plan.Additionally, all production processes were found to have been properly followed, and no issues were found during the guide's quality analysis.The trajectory deviation may have been caused by an inaccurate registration due to excessive shine in the patient scan.Please see attached to reference the detailed analysis.

Event Description

The guide was used for implant surgery, which resulted in the successful placement of implant #5.However, implant #4 perforated the buccal wall during placement.The implant was removed, and the site was tissue flapped and grafted.The doctor plans on submitting a new ct scan for a guide remake once the patient heals.

• 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: 10786051
• MDR Text Key: 214582901
• Report Number: 3008272529-2020-00014
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• 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: 10/28/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2020
• 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: 77 YR