• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOMET 3I DENTAL DRIVER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BIOMET 3I DENTAL DRIVER Back to Search Results
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Information (3190)
Event Type  Injury  
Manufacturer Narrative
Zimmer biomet complaint (b)(4). Device was not returned.
 
Event Description
It was reported that during implant placement while transferring the implant into patient mouth, an unknown biomet driver disengaged the implant prior placement and implant dropped on the floor. Procedure could not be completed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceDENTAL DRIVER
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 Key9328297
MDR Text Key166956989
Report Number0001038806-2019-01396
Device Sequence Number1
Product Code DZN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/07/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 11/15/2019 Patient Sequence Number: 1
-
-