MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® TITANIUM ABUTMENT 4.1MM

Model Number N/A

Device Problems Loss of or Failure to Bond (1068); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 02/04/2014

Event Type  malfunction  

Event Description

It was reported that, abutment, abutment screw and crown came out while the patient was sleeping.Product cannot be found.The patient thinks that she may have swallowed it.

Manufacturer Narrative

Death or serious injury did not occur.Medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure did not occur.A device malfunction did not occur.However, in an abundance of caution, a mdr is being filed as it is recognized that the possibility exists that the ingestion of certain devices and/or the ingestion of devices by individuals with certain health conditions may increase the likelihood that death, serious injury or medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure may occur.

• Brand Name: CERTAIN® BELLATEK® TITANIUM ABUTMENT 4.1MM
• Type of Device: CERTAIN® BELLATEK® TITANIUM ABUTMENT 4.1MM
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766906
• MDR Report Key: 3648591
• MDR Text Key: 20712384
• Report Number: 0001038806-2014-00019
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 02/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: IEDAT4
• Device Lot Number: 8143343-1
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention