MAUDE Adverse Event Report: BIOMET 3I GOLD-TITE SQUARE UNISCREW; DENTAL SCREW

Catalog Number UNISG

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

Event Description

The doctor reports a fixed metal-ceramic bridge screwed with abutments on #44 and #46 and a pontic on #45.The doctor notes that both goldtite components broke in 2021 and broke again in 2023.The procedure was concluded by placing two additional screws without any impact on the patient.The doctor reported: bruxism bone type: ii.

Manufacturer Narrative

Zimvie complaint number (b)(4).D10: concomitant medical product and therapy dates: unisg, gold-tite® square uniscrew, lot number: 1246019.

• Brand Name: GOLD-TITE SQUARE UNISCREW
• 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18496419
• MDR Text Key: 332738100
• Report Number: 0001038806-2024-00050
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNISG
• Device Lot Number: 1246019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2023
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DENTAL SCREW
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic