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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nerve Damage (1979); Numbness (2415)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

Process evaluation did not show any production error.We suspect that issue is related to the manner in which dr positioned the implant in the treatment plan.Additionally, the instrumentation discrepancy which would have contributed to the depth deviation.

Event Description

Post op scan showed drills went further than planned, but they were still far enough away from the nerve so dr left implants in.Patient came back after a few days with numbness and than it turned into pain.Dr believed that nerve was pierced thus he removed implants.

• 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 savaliya ; 303 almaden blvd.; suite 700; san jose, CA 95110 ; 4088851474
• MDR Report Key: 7660452
• MDR Text Key: 113159533
• Report Number: 3008272529-2018-00021
• 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: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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: 37 YR