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 12/10/2021

Event Type  Injury  

Manufacturer Narrative

Based on our investigation, we can conclude that all production processes were properly followed, and the correct final plan was used in fabrication.No issues were found during the guide's quality analysis, and both implant sites passed their trajectory analysis.The trajectory deviations may have been due to immediate extractions at the implant sites or may have been due to an inaccurate registration.

Event Description

The guide was used for implant surgery.The doctor stated that after performing surgery, the implants were slanting left.Surgery was aborted and the patient was grafted, and the doctor will submit new materials for a remake once the patient has healed.The doctor also stated that he believes we may have used the initial plan for fabrication, instead of his approved final plan.

• 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: tim nguyen ; 3350 scott blvd. bldg 29; santa clara, CA 95054 ; 4088851474
• MDR Report Key: 13228248
• MDR Text Key: 284806747
• Report Number: 3008272529-2021-00026
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2021
• 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: 44 YR
• Patient Sex: Male