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

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 07/02/2019

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that all production processes were properly followed.No issues were found during the guide's quality analysis, and the returned guide seated well on the dental model.The fit issue may have been caused by an inaccurate intra-oral scan, which was difficult to detect due to shine present in the patient scan.Additionally, performing surgery using an ill-fitting guide likely led to the trajectory deviation.Doctors are advised not to use the surgical guide for surgery if it does not seat properly as its accuracy may be impacted.Sg006 - anatomage guide technical datasheet (rev i) is shipped with every guide and instructs doctors to not use the guide if significant seating issues persist.In this case, the doctor acknowledged that it did not seat well, but chose to proceed with surgery.Therefore, the likely cause of the adverse event (buccal plate perforations) is the decision to use an ill-fitting guide for surgery.

Event Description

Surgery occurred on (b)(6) 2019.The guide did not seat properly, but the doctor chose to proceed with surgery.This caused the trajectory to deviate and he stated that during drilling he "blew out bone completely".The implant was left in, but was eventually removed on (b)(6) 2019.The doctor has since performed a bone graft, and submitted materials for a guide remake.Surgery was performed on (b)(6) 2019, but the complaint was not reported by the doctor until (b)(6) 2019.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose CA 95110
• Manufacturer (Section G): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose CA 95110
• Manufacturer Contact: meera kler ; 303 almaden blvd.; suite 700; san jose, CA 95110
• MDR Report Key: 9521960
• MDR Text Key: 188814949
• Report Number: 3008272529-2019-00031
• 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: 12/26/2019

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: 12/02/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2019
• 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