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); Perforation (2001)

Event Date 05/25/2021

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that all production processes were properly followed.The fit issue may have been caused by stone model inaccuracies which were difficult to detect due to excessive shine being present in the patient scan.Proceeding with surgery using the ill-fitting guide, in addition to the implant's planned proximity to the buccal plate, likely led to its perforation.In the technical data sheet that ships with every guide, doctors are advised against performing surgery with the guide if seating issues persist.

Event Description

The guide was used for implant surgery.The doctor's maxillary drp guide did not seat properly and rocked on the patient, and without someone holding it in place, there was a gap between the guide and the patient's facial anatomy.The doctor proceeded with surgery, and had an assistant hold the guide down throughout the procedure.However, while performing the osteotomy for site #9, the buccal wall was perforated.The doctor attempted to free-hand the remaining procedures for site #9, but was unable to successfully place the implant.The site was grafted, as was previously planned by the doctor due to very limited bone at the site.Site #5 was partly free-handed and was placed successfully.The doctor also ordered a mandibular drp guide, for which no issues were reported.

• 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: 12013822
• MDR Text Key: 256685401
• Report Number: 3008272529-2021-00013
• 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: 06/15/2021

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2021
• Initial Date FDA Received: 06/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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: 58 YR