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

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

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that the trajectories of the returned guide align with the doctor's approved final plan.Additionally, all production processes were found to have been properly followed.The cause of the trajectory deviation for site #29 could not be determined, and may have been caused by other complex clinical aspects outside the scope of this investigation.For site #30, the drill's failure to make contact with bone was likely due to limited bone being available after the extraction, which the doctor understood was a possibility during case planning.

Event Description

The guide was used for implant surgery.After using the guide, the doctor stated that the osteotomy for site #29 appeared further buccal than planned.She confirmed this using directional pins prior to implant placement, and decided not to place the implant and grafted the site instead.For site #30 the doctor performed atraumatic extraction (crown/roots were broken down into smaller parts and removed), in an attempt to preserve as much bone as possible.However, the drill was unable to make contact with bone, and the doctor understands that this was a possibility due to the extraction.The site was grafted and implant placement will be attempted at a future date.

• 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: 12222236
• MDR Text Key: 263377496
• Report Number: 3008272529-2021-00017
• 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: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• 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: 07/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2021
• 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: 69 YR