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

Catalog Number IUNIHG

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

Device lot number not provided/unknown.

Event Description

It was reported that the abutment screw loosened in tooth location 3.

Manufacturer Narrative

One certain® gold-tite® hexed screw was returned for inspection.A visual inspection revealed that the collar, drive feature, and body are noted to be worn, indicating use.No device lot number was provided so a device history record review and a complaint history review could not be performed.Appropriate documentation was reviewed and the following information was identified: biomet 3i restorative manual instrm rev c 09/16 the biomet 3i restorative manual was confirmed to contain instruction on screw placement as well as recommended torque values.In the case of gold-tite tm hexed uniscrews, it is recommended to torque at 20ncm.A singular cause could not be determined with the information provided as the event cannot be recreated.Complaint is therefore non-verifiable.

• 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: 7150630
• MDR Text Key: 96021033
• Report Number: 0001038806-2017-00948
• 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: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1