• 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 CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT

  • 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 CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H); DENTAL ABUTMENT Back to Search Results
Catalog Number ILPC342U
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/23/2023
Event Type  malfunction  
Event Description
The doctor reports that the dental abutment located in position number #14 failed because it fractured by the screw.The doctor reports that the procedure was not concluded by placing another abutment.Bone type: unknown.
 
Manufacturer Narrative
Zimvie complaint number (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(H)
Type of Device
DENTAL ABUTMENT
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
carlos gordian-arroyo
4555 riverside drive
palm beach gardens, FL 33410
5619713230
MDR Report Key18973217
MDR Text Key338522263
Report Number0001038806-2024-00560
Device Sequence Number1
Product Code NHA
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K092341
Exemption Number5645646
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Dentist
Type of Report Initial
Report Date 03/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/25/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue NumberILPC342U
Device Lot Number2022100421
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2024
Is the Reporter a Health Professional? Yes
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 Unknown
Patient Sequence Number1
Patient Age65 YR
Patient SexFemale
Patient EthnicityNon Hispanic
-
-