MAUDE Adverse Event Report: NOBEL BIOCARE USA, LLC SCREWDRIVER MANUAL UNIGRIP 28MM

Catalog Number 29149

Device Problem Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The initial reporter has been contacted to get additional follow up on the status of the patient.

Event Description

A nobel biocare manual unigrip 28mm screwdriver was used during a dental procedure to tighten a screw in the mouth of a male patient on (b)(6) 2015.The screwdriver slipped out of the hand of the clinician and, inadvertently, it was swallowed by the patient.On (b)(6) 2015, nobel biocare received information via telephone contact from the initial reporter, through our company representative, that a surgical procedure had been conducted and the screwdriver was removed from the patient.After the surgical procedure, the patient was reported to be doing well.

• Brand Name: SCREWDRIVER MANUAL UNIGRIP 28MM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): NOBEL BIOCARE USA, LLC; yorba linda CA
• Manufacturer Contact: joann radovich ; 22715/22725 savi ranch parkway; yorba linda, CA 92887 ; 7142824800
• MDR Report Key: 5161427
• MDR Text Key: 28809076
• Report Number: 2027971-2015-00001
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 29149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention