MAUDE Adverse Event Report: BIOMET 3I CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(H); DENTAL SCREW

Catalog Number ILPC442U

Device Problem Fracture (1260)

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

Event Date 03/04/2024

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint number (b)(4).

Event Description

It was reported locator and screw fractured.Doctor was able to retrieve fractured piece from implant.No further impact, patient will return for replacement.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 2MM(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: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18999494
• MDR Text Key: 338889206
• Report Number: 0001038806-2024-00610
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868021063
• UDI-Public: (01)00844868021063(17)280113(10)2022120370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092341
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ILPC442U
• Device Lot Number: 2022120370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2024
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic