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

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Code Available (3191)

Event Date 04/25/2019

Event Type  Injury  

Manufacturer Narrative

The investigation determined that the patient scan submitted by the doctor was taken on (b)(6) 2018.The related surgical guide case was requested on (b)(6) 2019 and fabrication completed on (b)(6) 2019.The surgery date was (b)(6) 2019.Therefore, the patient scan used to manufacture the guide was 14 months old by the time it was used for surgery.Per the technical data sheet that ships with each surgical guide, "anatomage guide is valid and functional for the duration of time that the intraoral morphology of the teeth and gingiva and their intraoral positions are identical to the morphology and positions of the teeth and gingiva as captured in the ct scan of the stone model from which the anatomage guide was produced." to account for shifts in patient morphology, anatomage procedure instructs technicians to check that the scan date is less than or equal to 6 months old.Therefore, the age of the patient scan should have been communicated to the doctor and a new scan should have been requested.As this expectation was not followed, it is possible that the manufactured guide deviated from the patient's current morphology as it was based on a 14 month old scan.The technicians involved have been re-trained to ensure scans older than 6 months are addressed with the doctor to obtain a more recent patient scan.The device was not returned after several requests to send it to anatomage for evaluation.Therefore, the most likely cause of this issue was the use of an outdated patient scan to manufacture the guide.[(b)(4)].

Event Description

The doctor used the surgical guide to perform drilling, however, the trajectory appeared to be off from the treatment plan.The doctor decided to abort surgery and graft the patient.

• 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: 8672299
• MDR Text Key: 147165728
• Report Number: 3008272529-2019-00009
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• 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: 75 YR