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

Catalog Number IUNIHG

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

Patient Problem No Information (3190)

Event Date 06/30/2015

Event Type  Injury  

Event Description

The dentist reported the abutment screw broke off inside implant chamber, approximately 6mm.

Manufacturer Narrative

Upon visual inspection, the screw has fractured with only small particles remaining stuck inside the implant.The remaining portion of the screw remains attached to the restorative component.The internal hex of the implant has been stripped.A white residue remained on the external surface of the screw, indicative of patient contact.The device history record review did not provide any indication of a manufacturing deviation that would contribute to this 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: 5032968
• MDR Text Key: 24160867
• Report Number: 0001038806-2015-00775
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK072642
• 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: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• 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: 08/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention