MAUDE Adverse Event Report: BIOMET 3I; DENTAL SCREW

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 09/23/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint number (b)(4).A previous report was submitted under 0002023141-2020-01870 with incorrect mfr number.

Event Description

It was reported that the doctor wanted to restore the implant, but was unable to remove the screws with our srt drill and the implant was removed.On a follow up, it was also reported that the abutment screw got stuck inside the implant.Abutment screw fractured and implant at tooth site 19 was removed.Patient has been rescheduled for new implant placement.

Manufacturer Narrative

Zimmer biomet complaint number one full osseotite® certain® implant 5 x 10mm (ifos510) and one unknown biomet screw were returned for investigation.Visual evaluation of the as returned products identified screw fragment in the drive feature of an implant that was severely fractured and damaged.Device history record (dhr) & complaint history review (unknown biomet screw): dhr and complaint history review could not be performed as the lot/item number was not available.However, zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products within specifications.Therefore, based on the available information, device malfunction did occur and the reported events were confirmed.

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: 11036746
• MDR Text Key: 222314549
• Report Number: 0001038806-2020-02086
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR