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

Catalog Number FRKIT

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

It was reported that the removal screws from the implant removal kit (frkit) fractured in the implants.The fractured portions of the screws were unable to be removed which led to implant removal by trephine.

• 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: 7717712
• MDR Text Key: 114943786
• Report Number: 0001038806-2018-00696
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FRKIT
• Device Lot Number: T030216070220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/26/2018
• Event Location: Other
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention