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

Catalog Number IUNIHT

Device Problem Fracture (1260)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that the abutment screw fractured in the implant.Removal tools purchased, a replacement screw was requested to be sent out and the patient will be returning end of december for screw removal.

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The following sections have been updated: d9: device available for evaluation change ¿no' to 'yes.'.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The reported device was returned for investigation.Visual evaluation of the returned product identified no signs of use and product still sealed inside original package.Functional testing could not be performed due to the nature of event and device.Pre-existing patient conditions and implantation period are unknown due to limited information provided by the customer.Picture images were not provided.A device history record (dhr)review was performed and no related deviations or nonconformances were noted.Also, a complaint history search was performed using our complaint handling system and there were no additional related complaints for this product lot.Complainant reported that the abutment screw fractured.The reported complaint could not be verified.A definitive root cause for this complaint could not be determined.

Event Description

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

• Brand Name: CERTAIN® TITANIUM HEXED SCREW
• Type of Device: DENTAL IMPLANT
• 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: 13067530
• MDR Text Key: 284301186
• Report Number: 0001038806-2021-02413
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: IUNIHT
• Device Lot Number: 1248981
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male