MAUDE Adverse Event Report: BIOMET 3I CERTAIN® GOLD-TITE® HEXED SCREW; ABUTMENT SCREW

Catalog Number IUNIHG

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

The dentist reported the abutment screw fractured resulting in the implant at tooth site #12 having to be removed.

Manufacturer Narrative

This device was reported discarded by the dentist.Discarded.

Manufacturer Narrative

Evaluation results code: fracture problem unable to be selected.Upon visual inspection, it was confirmed that the screw has fractured with a portion remaining stuck inside the implant.The remaining portion of the screw has not been returned.No lot number was provided for the screw therefore the device history record could not be reviewed.However, a review of the implant lot was performed and there was no indication of a manufacturing deviation that would contribute to this event.A complaint history review was performed on the implant lot and no additional complaints have been initiated against this lot for a similar event.A definitive root cause has not been determined.(b)(4).

• Brand Name: CERTAIN® GOLD-TITE® HEXED SCREW
• Type of Device: ABUTMENT SCREW
• 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: dania perez ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 4800935
• MDR Text Key: 5925597
• Report Number: 0001038806-2015-00681
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: PK072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR