MAUDE Adverse Event Report: NEOBIOTECH CO. LTD. FIXTURE REMOVER SCREW M2.0

Catalog Number FRS20

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 11/09/2016

Event Type  No Answer Provided  

Event Description

The dentist reported that fixture removal screw fractured.The dentist had to remove bone to remove the implant.

• Brand Name: FIXTURE REMOVER SCREW M2.0
• Type of Device: FIXTURE REMOVER SCREW
• Manufacturer (Section D): NEOBIOTECH CO. LTD.; e-space #105,; 212-26 guro-dong; guro-gu, seoul 152-7 89; KS 152-789
• MDR Report Key: 6145426
• MDR Text Key: 61447813
• Report Number: 0001038806-2016-00319
• Device Sequence Number: 1
• Product Code: DZA
• 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: Dentist
• Type of Report: Initial
• Report Date: 12/05/2016,11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2016
• 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: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/09/2016
• Event Location: Other
• Date Report to Manufacturer: 12/05/2016
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR