MAUDE Adverse Event Report: BIOMET 3I LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H); DENTAL SCREW

Catalog Number LPC341U

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the abutment fractured at the screw of the abutment inside the implant and the abutment was removed.Tooth location 35.

Manufacturer Narrative

Zimvie complaint number (b)(4).E1: reporter phone: (b)(6).

• Brand Name: LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H)
• Type of Device: DENTAL SCREW
• 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 ; 5619713230
• MDR Report Key: 18408352
• MDR Text Key: 331476367
• Report Number: 0001038806-2023-02504
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868020998
• UDI-Public: (01)00844868020998(17)251109(10)2020100633
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092341
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: LPC341U
• Device Lot Number: 2020100633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic