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

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

Patient Problem Injury (2348)

Event Date 08/05/2020

Event Type  Injury  

Manufacturer Narrative

According to our investigation, performing the osteotomy using the required drill length should have resulted in drill reaching the planned depth.However, due to the implant being changed for compatibility reasons, the prescribed implant mount resulted in the implant being placed 2 mm more apical than planned.The cause of the additional 1 - 2 mm of depth that the doctor observed could not be determined, and it is unclear how the doctor produced this measurement.

Event Description

The doctor used the guide for implant surgery.The doctor was placing 15 mm implants at sites #29 and #30.After performing the osteotomy for site #30, the doctor measured its length (including the soft tissue), as being 15 mm.However, when placing the implant, it was 3-4 mm deeper than he had wanted.He does not believe the guide flexed at all, and thinks that the implant mount listed on the reference chart may have been 2 mm too long.The implant was backed out to the desired depth, and implant #29 was placed without issue.

• 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: 10627336
• MDR Text Key: 209816360
• Report Number: 3008272529-2020-00010
• 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: 10/02/2020

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: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 10/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2020
• 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: 80 YR