MAUDE Adverse Event Report: NEOBIOTECH FIXTURE REMOVER SCREW M 2.0; SCREW REMOVAL TOOL

Catalog Number FRS20

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/27/2017

Event Type  Injury  

Event Description

Doctor reports that they were attempting to remove an implant and the frs20 tool fractured in the process.Consequently, the patient had to have the implant trephined out.

Manufacturer Narrative

Device available for evaluation changed from "no to yes".

• Brand Name: FIXTURE REMOVER SCREW M 2.0
• Type of Device: SCREW REMOVAL TOOL
• Manufacturer (Section D): NEOBIOTECH; #105, 212-26 guro-dong; guro-gu; seoul
• MDR Report Key: 7129664
• MDR Text Key: 95249413
• Report Number: 0001038806-2017-00919
• 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,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Dentist
• Device Catalogue Number: FRS20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/05/2017
• Date Manufacturer Received: 12/18/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention