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

Model Number IUNIHT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).

Event Description

It was reported screw loosening.Screw was placed on (b)(6) 2021.Patient is diabetic.Patient has been rescheduled for new screw placement.

Manufacturer Narrative

Zimmer biomet (b)(4).One certain gold-tite hexed screw (iunihg) was returned for investigation.Visual evaluation of the returned product, identified signs of use, but no apparent malfunction.Functional testing was performed.And screw engaged with in-house device normally.No pre-existing conditions were noted.The device had been placed on a tooth location (b)(6) fdi, for approximately 2 months.Review of appropriate documentation: documents reviewed: biomet 3i restorative products ifu (p-iis086gr) rev f - october 2019.Information identified: warnings, precautions and potential adverse events.Per the applicable ifu, under section precautions, it is stated that improper technique could cause screw loosening.Dhr review: dhr review could not be performed, as the lot number associated with the reported device was not available.However, zimmer biomet quality management system (qms), has controls in place to ensure the distribution of conforming products within specifications.Complaint history review: a year-long complaint history review by item number (iunihg), was performed for similar events using keyword screw loosening.And no complaint about nonconforming products was identified.Post market trend review: october post market trending was reviewed.And there were no actionable events or corrective actions for the reported event (functional: loosening) or product (iunihg).Therefore, based on the available information, device malfunction has not occurred.And the reported events could not be verified, as the exact details of event were non-verifiable.

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: 12369526
• MDR Text Key: 270068086
• Report Number: 0001038806-2021-01611
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868008545
• UDI-Public: (01)00844868008545(17)260314(10)1244066
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072642
• 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,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IUNIHT
• Device Catalogue Number: IUNIHG
• Device Lot Number: 1244066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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: 58 YR
• Patient Sex: Female