MAUDE Adverse Event Report: NEOBIOTECH CO. LTD. IMPLANT REMOVAL KIT; DENTAL IMPLANT REMOVAL KIT

Catalog Number FRKIT

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 06/16/2018

Event Type  Injury  

Event Description

It was reported that the implant removal kit (frkit) failed to remove a zimmer biomet implant during a procedure.The implant was removed using a surgical extraction approach.

• Brand Name: IMPLANT REMOVAL KIT
• Type of Device: DENTAL IMPLANT REMOVAL KIT
• Manufacturer (Section D): NEOBIOTECH CO. LTD.; e-space #1010, guro-dong; guro-dong, seoul 152-7 89; KS 152-789
• MDR Report Key: 7715822
• MDR Text Key: 114895994
• Report Number: 0001038806-2018-00695
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FRKIT
• Device Lot Number: T030217110160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/25/2018
• Event Location: Other
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention