MAUDE Adverse Event Report: BIOMET 3I CERTAIN HEX.TRY-IN SCREW; TRY-IN ABUTMENT SCREW

Catalog Number IUNITS

Device Problem Fracture (1260)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

Product not returned to manufacturer.

Event Description

The dentist reported that abutment screw fractured and part remains in implant.

Manufacturer Narrative

During visual and 10 x magnification inspection of the returned screw and based on dimensional inspection, the iunihg was not consistent with its drawing, but it was rather consistent with iunits.Screw returned by customer was a try-in screw and is not intended used intro-oral use with final restorations.The try-in screw was fractured.The complaint was confirmed.The lot number was not provided; therefore, a device history record review could not be completed.A definitive root cause has not been determined.

Event Description

The try-in abutment screw was place on (b)(6) 2014 and removed on (b)(6) 2017.Patient's crown came out due screw fractured.

• Brand Name: CERTAIN HEX.TRY-IN SCREW
• Type of Device: TRY-IN 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: 6254661
• MDR Text Key: 65264138
• Report Number: 0001038806-2017-00017
• Device Sequence Number: 1
• Product Code: NDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• 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: 12/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNITS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2017
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR