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 complaint number (b)(4).Age and date of birth unknown / not provided.Weight unknown / not provided.Date of event unknown / not provided.Brand name unknown / not provided.Device product code unknown / not provided.Lot/serial # unknown / not provided.Device expiration date unknown / not provided.Device udi number unknown / not provided.Pma/510(k) number unknown / not provided.Device manufacturer date unknown / not provided.

Event Description

It was reported the abutment was placed (b)(6) 2017 abutment and crown came out in patients hand approx.Date end of (b)(6) 2017.(loosening occurred).Tooth location unknown.

Event Description

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

Manufacturer Narrative

One unknown 3i abutment, one unknown 3i screw and one 3i t3® with dcd® tapered implant were not returned for investigation.Therefore, visual evaluation could not be performed.Several loosening and other events were reported and addressed/will be addressed under other complaints.This investigation only addresses one loosening event using applicable instructions for use and risk files as the products were not returned.Functional testing could not be performed since the products were not returned.No pre-existing conditions were reported.The devices had been placed on tooth #14 (universal) for an unknown amount of time when the incident occurred.X-ray or picture images were not provided.Appropriate documentation was reviewed.Dhr and complaint history review could not be performed as the lot/item numbers were not provided/available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Dhr review (b)(4): dhr review was completed for the subject lot number (2015111161).It was confirmed that all operations and inspections were executed as per applicable procedures.No deviations or non-conformances, which could have caused or contributed to the reported event were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review (b)(4): complaint history review was completed for the subject lot number (2015111161) and no other complaints about nonconforming products were identified.Based on the available information, device malfunction and the reported event could not be verified since the products were not returned.

• Type of Device: DENTAL SCREW
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 10727832
• MDR Text Key: 214573802
• Report Number: 0001038806-2020-01660
• Device Sequence Number: 1
• Product Code: DZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention