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

Device Problem Compatibility Problem (2960)

Patient Problem Injury (2348)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that the drill depth of the surgical guide aligns with the drill depth prescribed in the reference chart.However, the reference chart was produced for the astra facilitate kit, while the doctor used the astra ev kit.This was due to the fact that the internal software used to virtually create the guide is currently incompatible with astra ev, which led to our consultant changing the implant types to astra facilitate which is compatible.This subsequently led to the depth discrepancy because the two astra systems have different drill protocols.Identification of appropriate corrective actions is in-process to mitigate such issues in the future.A follow-up report shall be submitted as necessary.

Event Description

The doctor used the guide for implant surgery.After using the guide to place implants #5, #10, and #12, the doctor believed that they were placed deeper than intended.He tissue flapped the sites, and visually observed that all three sites were approximately 2 mm sub-crestal, which was not reflected in the final plan.He also took periapical x-rays of each site, which confirmed that the implants were placed deeper than planned.All three sites were backed up to crestal level and left in.The doctor also placed an implant at site #7.However, the guide was only used for the initial pilot osteotomy, and the doctor free-handed the remainder of surgery.

• 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: 10221971
• MDR Text Key: 197570827
• Report Number: 3008272529-2020-00005
• 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: 06/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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