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

Catalog Number IUNIHG

Device Problem Fracture (1260)

Patient Problem Bruxism (4427)

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).

Event Description

It was reported that screw fractured and it was removed.

• Brand Name: CERTAIN GOLD-TITE HEXED SCREW
• Type of Device: DENTAL 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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18742774
• MDR Text Key: 335786368
• Report Number: 0001038806-2024-00267
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K072642
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1255705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2022
• 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: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic