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

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

Patient Problem Failure of Implant (1924)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that the guide was fabricated for the incorrect drill length due to an internal error.However, the returned guide passed its trajectory analysis, and the longer drill length should not have contributed to the trajectory deviation.As such, the cause of the deviation could not be determined, and may have been due to complex clinical aspects outside the scope of this investigation.

Event Description

The guide was used for implant surgery.The doctor stated that the guide sat well on the dental model and patient.However, it was fabricated for a 21 mm drill instead of for a 15mm drill as he had requested.Additionally, after using the pilot drill, he noticed that the osteotomy was closer to tooth #4 than intended.He decided to trust the guide and proceeded with surgery, but the implant ended up being ~1-1.5mm from the root of tooth #4 which was closer than planned.The implant was removed at a later date, and the doctor grafted the site.

Manufacturer Narrative

Based on our investigation, we can conclude that the guide was fabricated for the incorrect drill length due to an internal error.However, the returned guide passed its trajectory analysis, and the longer drill length should not have contributed to the trajectory deviation.As such, the cause of the deviation could not be determined, and may have been due to complex clinical aspects outside the scope of this investigation.

Event Description

The guide was used for implant surgery.The doctor stated that the guide sat well on the dental model and patient.However, it was fabricated for a 21 mm drill instead of for a 15mm drill as he had requested.Additionally, after using the pilot drill, he noticed that the osteotomy was closer to tooth #4 than intended.He decided to trust the guide and proceeded with surgery, but the implant ended up being ~1-1.5mm from the root of tooth #4 which was closer than planned.The implant was removed at a later date, and the doctor grafted the site.

• 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: tim nguyen ; 3350 scott blvd. bldg 29; santa clara, CA 95054 ; 4083333484
• MDR Report Key: 13063489
• MDR Text Key: 285615982
• Report Number: 3008272529-2021-00025
• 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: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2021
• 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: 50 YR
• Patient Sex: Female