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 06/22/2020

Event Type  Injury  

Manufacturer Narrative

The cause of the fit issue could not be determined.However, it was determined that the block-out that was present did not contribute, and no issues were found during the software and fabrication phases.The registration of the stone model to the patient scan was acceptable, and the guide passed its quality analysis.Additionally, while the cause of the fit issue could not be determined, proceeding with surgery using the poorly-fitting guide most likely led to the observed trajectory deviation.As such, all guides are shipped with a technical data sheet which directs users to ensure that the guide is seated accurately before drilling, and warns that the guide should not be used if seating issues persist.See attached to reference the supporting analysis for additional details.If the surgical guide is returned, it will be evaluated and the report shall be updated as appropriate.

Event Description

The doctor used the guide for implant surgery.The doctor stated that after placing the guide it was rocking on the patient, which the doctor believes may have been due to block-out added by anatomage technicians to address a discrepancy between the stone model and patient scan.He continued with the osteotomy, but realized that it was too buccal.Surgery was aborted and the patient was grafted.

Event Description

The doctor used the guide for implant surgery.The doctor stated that after placing the guide it was rocking on the patient, which the doctor believes may have been due to block-out added by anatomage technicians to address a discrepancy between the stone model and patient scan.He continued with the osteotomy, but realized that it was too buccal.Surgery was aborted and the patient was grafted.Note: this report was revised due to receipt of the surgical guide.

Manufacturer Narrative

The cause of the fit issue could not be determined.However, it was determined that the block-out that was present did not contribute, and no issues were found during the software and fabrication phases.The registration of the stone model to the patient scan was acceptable, and the guide passed its quality and trajectory analyses.Additionally, while the cause of the fit issue could not be determined, proceeding with surgery using the poorly-fitting guide most likely led to the observed trajectory deviation.As such, all guides are shipped with a technical data sheet which directs users to ensure that the guide is seated accurately before drilling, and warns that the guide should not be used if seating issues persist.See attached to reference the supporting analysis for additional details.

• Brand Name: ANATOMAGE GUIDE
• Type of Device: SURGICAL GUIDE
• Manufacturer (Section D): ANATOMAGE INC.; 303 almaden blvd.; suite 700; san jose, ca
• MDR Report Key: 10228367
• MDR Text Key: 197978099
• Report Number: 3008272529-2020-00006
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

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: 07/08/2020
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR