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

Model Number N/A

Device Problems Fracture (1260); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when doctor was examining the patient, he discovered that one low profile abutment ( ilpc343u) had fractured.

Manufacturer Narrative

This report is being submitted to supplement.Two certain low profile one-piece abutments were returned for inspection with a piece of a low profile abutment screw.Both devices show signs of wear from use.One of the abutments is confirmed to be fractured at the threaded regions.The drive feature of the other abutment is confirmed to contain half of a fractured low profile abutment screw.The hex of the low profile abutment screw is similarly worn.The reported conditions of one fractured low profile abutment and one low profile abutment with a screw fractured into the driver feature were confirmed.The reported event could not be recreated due to the already damaged states of the devices and the nature of the alleged event.No issues were identified during investigation that show that the reported device could have caused or contributed to the reported event.A device history review and complaint history review could not be performed as the lot number of the reported devices are unknown.A definitive root cause could not be determined.Probable causes related to this event include customer error in screw torqueing or potential cross-threading, excessive occlusal forces, inadequate abutment torque, and ill fitting framework.

Event Description

It was reported that during a visit, the doctor was checking the patient and discovered two retaining screws and one low profile abutment were fractured.For one of the screws, the retaining part got stuck in the abutment.The abutment and stuck screw were removed.For the second screw, the doctor realized that the abutment (ilpc343u) was also fractured at the screw level.The fractured abutment was removed.There was no report of patient injury.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 3MM(H)
• Type of Device: ONE PIECE ABUTMENT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7929491
• MDR Text Key: 122633590
• Report Number: 0001038806-2018-00856
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• PMA/PMN Number: PK092341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: ILPC343U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1