MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet (b)(4).Patient identifier unknown / not provided.Weight unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Catalog,lot, udi number unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported that after a week , crown was loose due to screw loosening.To remove the crown it was perforated as it was a cemented crown.

Event Description

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

Manufacturer Narrative

Zimmerbiomet complaint number cmp-0641498 the following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one unknown biomet screw was returned for investigation.Visual evaluation of the as returned product identified signs of wear due to usage.The device had no apparent signs of malfunction.Functional testing could not be performed due to the nature of the device and event.No pre-existing conditions were noted on the per.The device had been placed on an unknown tooth location for approximately 1 week.X-ray or picture images were not provided.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.Also, according to the ifu, patient factors like presence of occlusal abnormalities or parafunctional habits (e.G.Severe bruxism, clenching, overloading, or gnawing) may cause screw loosening, restoration fracture, and/or implant failure.Dhr and complaint history review could not be performed as the lot/item number was unknown.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.November post market trending was reviewed and there were no actionable events or corrective actions for the reported event or product.Therefore, based on the available information, device malfunction did not occur.However, the reported event could not be verified as the exact details of event were nonverifiable.

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10769796
• MDR Text Key: 215939347
• Report Number: 0001038806-2020-01713
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 01/04/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR