MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Unintended Movement (3026)

Patient Problem No Information (3190)

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 and udi number unknown / not provided.Pma/510(k) number not available.

Event Description

It was reported that after 3 weeks crown was loose due to screw loosening.Screw was removed, to remove it, the crown was perforated as it was a cemented crown.

Manufacturer Narrative

Zimmerbiomet complaint number (b)(4).The following sections have been updated: h3: device evaluated by manufacturer: change ¿no' to 'yes.' one unknown biomet screw and an associated item (unknown abutment) were returned for investigation.Visual evaluation of the as returned products identified signs of wear on the devices due to usage.Per complaint description, the screw had loosened and had to be removed by drilling through crown and abutment which resulted in abutment and crown damage.The investigation addressed only the screw and the loosening event since there were no allegations against the abutment.Functional testing was performed using an applicable in-house implant.The devices were able to assemble properly.No pre-existing conditions were noted on the per.The devices had been placed on an unknown tooth location for an unknown amount of time.X-ray or picture images were not provided.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 associated with the reported screw was not available.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 screw.Therefore, based on the available information and functional testing, device malfunction did not occur.Additionally, the reported event could not be verified as the exact details of event were nonverifiable.

Event Description

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

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10769697
• MDR Text Key: 215939523
• Report Number: 0001038806-2020-01710
• 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?: No
• 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: 01/05/2021
• Supplement Dates FDA Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR