MAUDE Adverse Event Report: NEOBIOTECH CO. LTD. FIXTURE REMOVER SCREW M1.8

Catalog Number FRS18

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/06/2015

Event Type  No Answer Provided  

Event Description

The dentist reported that fixture remover screw fractured in the attempt to extract the implant.The dentist milled out the implant to achieve the removal.Patient was re-scheduled for another surgery for re-implantation.

• Brand Name: FIXTURE REMOVER SCREW M1.8
• Type of Device: FIXTURE REMOVER SCREW
• Manufacturer (Section D): NEOBIOTECH CO. LTD.; e-space #105; 212-26 guro-dong; guro-gu, seoul 152-1 89; KS 152-189
• MDR Report Key: 6181314
• MDR Text Key: 62597600
• Report Number: 0001038806-2016-00346
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 11/25/2016,11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: FRS18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2016
• Event Location: Other
• Date Report to Manufacturer: 11/25/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR