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

Catalog Number IUNIHG

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

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Discarded.

Event Description

The dentist reported patient's crown and abutment came off; the screw had fractured.The screw was removed from the implant.

Manufacturer Narrative

The product associated with this complaint was not returned.The complaint could not be verified.The lot number for the screw was not provided and therefore a device history record review could not be completed.A definitive root cause has not been determined.

• 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: 5899875
• MDR Text Key: 52860962
• Report Number: 0001038806-2016-00213
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date: 07/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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