MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE 17° ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

Catalog Number ILPAC3217

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2015

Event Type  malfunction  

Manufacturer Narrative

Visual inspection confirmed that the screw had fractured near the tip.The fractured component remained inside the abutment, which was still attached to the mating implant.There was evidence of discoloration and wear of the returned screw.The cause for the fracture could not be determined.Review of the device history record and visual inspection did not provide any indication of a manufacturing deviation that would contribute to this event.(b)(4).

Event Description

The doctor reported that during the placement of abutment, the screw portion broke off in the implant and could not be removed which lead to remove the of the implant.The doctor was able to place another implant and abutment during the same procedure.

Manufacturer Narrative

Device evaluation anticipated, but not yet begun.

• Brand Name: CERTAIN® LOW PROFILE 17° ABUTMENT 3.4MM(D) X 2MM(H)
• Type of Device: DENTAL ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; c/islas baleares, 50, pol. ind; valencia, ES 4 6988
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 4608355
• MDR Text Key: 13094003
• Report Number: 0001038806-2015-00520
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK092341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ILPAC3217
• Device Lot Number: 2014010943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIFNT3215