OSSEOCISION TM MICROMOTOR WITH CORD E211-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-06-25 for OSSEOCISION TM MICROMOTOR WITH CORD E211-001 manufactured by Nsk America Corp/nsk Dental Llc.

Event Text Entries

[6059511] The doctor states that while he was performing a surgical procedure using this drill unit, an error code was displayed and the hand piece stopped. He was unable to reconcile the error code and had to abandon the procedure. The doctor placed a graft and sutures. The patient will need to return in 3-4 months to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001038806-2015-00704
• MDR Report Key: 4868721
• Report Source: *
• Date Received: 2015-06-25
• Date of Report: 2015-05-27
• Date of Event: 2015-05-21
• Date Facility Aware: 2015-05-27
• Report Date: 2015-05-28
• Date Reported to Mfgr: 2015-05-28
• Date Added to Maude: 2015-06-25
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: DENTIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 3
• Manufacturer Country: US
• Single Use: 0
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: OSSEOCISION TM MICROMOTOR WITH CORD
• Generic Name: MICROMOTOR WITH CORD
• Product Code: EJB
• Date Received: 2015-06-25
• Returned To Mfg: 2015-06-09
• Catalog Number: E211-001
• Operator: DENTIST
• Device Availability: R
• Device Age: 1 YR
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NSK AMERICA CORP/NSK DENTAL LLC
• Manufacturer Address: 1800 GLOBAL PARKWAY HOFFMAN ESTATES IL 60192 US 60192

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2015-06-25