Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 ABUTMENT SCREW
  • 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 ABUTMENT SCREW Back to Search Results
Device Problem Fracture (1260)
Patient Problem No Information (3190)
Event Date 06/01/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Patient weight unknown / not provided.Brand name unknown / not provided.Device information unknown / not provided.
 
Event Description
It was reported that the unknown biomet abutment screw fractured in the integrated implant.The doctor was unable to remove the fractured screw portion and, as a consequence, the implant was removed.
 
Manufacturer Narrative
One osseotite implant was returned for inspection.The internal drive feature is confirmed to contain the reported fractured screw, which was too badly damaged to be removed.The alleged complaint is therefore confirmed.No device lot number was provided so a device history record review and a complaint history review could not be performed.A root cause for the complaint could not be determined.The following sections have been updated: device evaluated by mfr: changed "no" to "yes.".
 
Event Description
No further event information available at the time of this report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
DENTAL ABUTMENT SCREW
Manufacturer (Section D)
BIOMET 3I
4555 riverside drive
palm beach gardens FL 33410
MDR Report Key7798066
MDR Text Key117622128
Report Number0001038806-2018-00760
Device Sequence Number1
Product Code DZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 12/18/2018
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 Lay User/Patient
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/24/2018
Initial Date FDA Received08/20/2018
Supplement Dates Manufacturer Received11/19/2018
Supplement Dates FDA Received12/18/2018
Patient Sequence Number1
Treatment
IFNT510.; IFNT510
Patient Outcome(s) Required Intervention;
Patient Age65 YR
-
-