MAUDE Adverse Event Report: BIOMET 3I CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H)

Catalog Number ILPC343U

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/29/2015

Event Type  malfunction  

Manufacturer Narrative

Continuation of unique identifier (udi) # - (b)(4).

Event Description

The dentist reported that the screw portion broke off the abutment after restoration.The dentist was able to retrieve the entire portion of the screw that was in the implant.

Manufacturer Narrative

Upon visual inspection, the abutment screw portion was fractured.Some scratches were observed on the top portion of the abutment, but no significant damage.Based on product evaluation, complaint is confirmed.The device history record review was performed and the information did not provide any indication of a manufacturing deviation that contributed to the event reported.A definitive root cause has not been determined.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H)
• Type of Device: ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I DENTAL IBERICA SL; c/islas baleares, 50; pol. ind. fuente del jarro; paterna, valencia
• Manufacturer Contact: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 5105523
• MDR Text Key: 26960959
• Report Number: 0001038806-2015-00795
• 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: Followup
• Report Date: 09/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/13/2019
• Device Catalogue Number: ILPC343U
• Device Lot Number: 2013121414
• Other Device ID Number: (01)00844868021094(10)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1