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 07/22/2019

Event Type  Injury  

Manufacturer Narrative

The investigation determined that various potential causes could have contributed to the observation that the doctor did not reach bone as expected.These potential causes were unrelated to the production process.Although it was initially reported that the doctor used a drill that was 8.5 mm in length, follow-up communication confirmed that the doctor used an 18.5 mm drill for surgery.Based on the treatment plan and known nobel manufacturer information, the virtually planned drill depth for the implant site was 19.4 mm.The guide was returned and drill depth analysis was conducted.The analysis requires physical and virtual measurements in order to calculate the distance from the top of the handle and the apical end of the planned implant.It was calculated to be 19.33 mm which is within the internal tolerance of the planned depth.Production records were reviewed to consider any issues that may have occured.The case profile revealed that the technician had identified that the sleeve was impacting soft tissue and required a tissue flap.The required flap would have also impacted adjacent teeth.The issue was reported to the doctor who chose to free-hand 2.0 mm to clear the impaction.Therefore, in order to achieve the necessary depth, the doctor would have had to drill the required depth, remove the guide, and free-handed an additional 2 mm.This would result in a total planned drill depth of 21.4 mm.Since the doctor used an 18.5 mm drill and did not free-hand the additional 2 mm, his drill depth would be 2.9 mm short of what was planned.The guide had initially failed its final quality analysis due to inadequate sleeve stability.Sleeve support material was added around the sleeve, and the guide passed all subsequent testing.Therefore, the guide was verified to be acceptable prior to production release and shipment.As the doctor claimed to not reach bone, the distance from the top of the handle to the maxillary bone was assessed.The distance was virtually measured against the patient scan to be approximately 11 mm.Therefore, an 18.5 mm drill with a correctly seated guide should have caused the drill to engage bone.Trajectory analysis was also conducted because suspected trajectory deviations could also impact the depth.It was determined that the largest deviation observed was 0.23 mm at the implant's apex which is within the internal tolerance.Therefore, the trajectory was not deviated to the extent that it could have interfered with the depth.As there were no identified issues during production which could have impacted the depth, the likely potential causes are associated with operational context.If the doctor had used an 8.5 mm drill as the complaint had initially reported, it would have not reached the bone.Additionally, it is possible that the 18.5 mm drill was used, but it was not advanced to the drill stop.If the drill binded in the sleeve, the drill was too dull, or if patient morphology was challenging, it is possible that the drill could have been prevented from drilling to the stop.

Event Description

The doctor performed a tissue flap and seated the guide.He was unable to see the osteotomy site.When he used the drill, he reported that it did not seem to contact bone as it did not have the expected resistance.The doctor decided to abort the surgery and rescheduled his patient for a later date.An assistant stated that the doctor used an nobel drill that was 8.5 mm in length.

• 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: 8908179
• MDR Text Key: 155031566
• Report Number: 3008272529-2019-00015
• 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: 07/22/2019

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: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/22/2019
• Initial Date FDA Received: 08/19/2019
• 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: 48 YR