MAUDE Adverse Event Report: BIOMET 3I CERTAIN TITANIUM HEXED SCREW; DENTAL SCREW

Model Number IUNIHT

Device Problem Fracture (1260)

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

Event Date 11/23/2022

Event Type  malfunction  

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-01977.Zimmer biomet complaint number: (b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that screws at tooth sites #11 and #12 fractured and were removed.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

(b)(4).

• Brand Name: CERTAIN TITANIUM 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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5617766700
• MDR Report Key: 16051353
• MDR Text Key: 308539524
• Report Number: 0001038806-2022-01976
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IUNIHT
• Device Catalogue Number: IUNIHT
• Device Lot Number: 1248839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• 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: 69 YR
• Patient Sex: Female