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

Device Problem Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

Implant site #23 was the weakest point of the guide due to less coverage.Doctor might have applied too much pressure on the guide when a tissue punch was being done through it.As a result, guide fractured from site #23.

Event Description

When doctor was performing a tissue punch through the guide at site 23, the sleeve popped out and the guide fractured.

• Brand Name: ANATOMAGE INC.
• 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 savaliya ; 303 almaden blvd.; suite 700; san jose 95110 ; 4088851474
• MDR Report Key: 7470880
• MDR Text Key: 106873903
• Report Number: 3008272529-2018-00015
• 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
• Type of Report: Initial
• Report Date: 01/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2017
• 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: 50 YR