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

Catalog Number FRS20

Device Problem Fracture (1260)

Patient Problems No Information (3190); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was discarded by dentist.

Event Description

The dentist reported that the fixture removal screw fractured within the implant.The screw fragment was removed and the implant remains placed.

• 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 FL 152-7 89; KS 152-789
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 6130271
• MDR Text Key: 60990644
• Report Number: 0001038806-2016-00315
• Device Sequence Number: 1
• Product Code: DZA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/09/2016,10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Report to Manufacturer: 11/09/2016
• Date Manufacturer Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention