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

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

Patient Problem No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

The investigation determined that there were discrepancies in the materials provided by the doctor that could have led to a fit issue and subsequent trajectory issues.The intra-oral patient scan was missing an area of deep soft tissue on the buccal side of areas #3 - #6.This area should have prompted addition of heavy block-out either virtually or physically to correct the gap, but the software technician only indicated that "slight" block-out should be added during lab fabrication.Although the instruction was not appropriate to address the discrepancy, the affected area was ultimately trimmed during fabrication and not included in the guide.Therefore, the issue likely did not affect the fit of the guide.The patient scan quality submitted by the doctor was suboptimal and could have contributed to the fit issue.There was limited soft tissue separation throughout the scan, heavy shine in the posterior areas which obscured the shapes of teeth #4, 7, and 12-15, and the scan was taken with a closed bite which further obscured the shapes of the teeth.However, these factors alone did not necessitate a request for new materials as the registration was acceptable per procedural guidelines.The guide passed its quality analysis prior to shipment, confirming that the trajectories aligned with the dental model.The returned guide was determined to seat well on the dental model with stable sleeves.The trajectory analysis determined that the trajectory aligned well with the treatment plan and the deviation was within the standard tolerance of <0.5 mm.The doctor had planned and approved the treatment plan prior to fabrication.Therefore, the potential cause of the fit issue is likely inaccurate tooth anatomy in the intra-oral scan which would have been difficult to detect due to the aforementioned patient scan quality observations.As the guide did not fit properly, the planned trajectories likely deviated thus causing the adverse event.Doctors are advised to not use the guide for surgery if it does not seat properly in the patient's mouth.

Event Description

The doctor attempted to seat the guide, but found that it did not fit properly and rocked.The doctor decided to use the guide by pushing down on different areas to drill and placed the site 6 implant.The doctor observed that the placement looked more buccal than planned.The patient later complained of pain 1 week later and the doctor removed the implant and grafted the site.The guide was created for sites 3 and 6 but was only used to place the site 6 implant.

• 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: 8844198
• MDR Text Key: 152760473
• Report Number: 3008272529-2019-00014
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2019
• 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: 39 YR