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

Catalog Number ILPC442U

Device Problem Fracture (1260)

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

Event Date 02/04/2024

Event Type  malfunction  

Manufacturer Narrative

Zimvie complaint (b)(4).

Event Description

It was reported that the implant at tooth site # 30 was removed as the abutment screw broke.Abutment screw broke off inside of the implant while it was being screwed in.Torque had not been placed on the abutment screw.A new implant and a new low profile abutment were used to complete the diem surgery.

Manufacturer Narrative

This report is being submitted to report additional and corrected information to 0001038806-2024-00296.Follow up with customer confirmed the concomitant item and lot number.Further evaluation confirmed that the event is a reportable malfunction, not a serious injury as was reported incorrectly in the initial medwatch submission.The following sections are being reported: b1.Report type (check all that apply) is corrected.D5: operator of device is corrected.D10: t3pt5410, t3 pro tapered implant 5/4mm (d) x 10mm (l), lot number 2023041077.H1: type of reportable event is corrected.H2: if follow-up, what type.H6: impact code is corrected.H10: additional narratives/data.

Event Description

No additional or corrected information to report.

• Brand Name: CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(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 Key: 18767459
• MDR Text Key: 336111845
• Report Number: 0001038806-2024-00296
• Device Sequence Number: 1
• Product Code: NHA
• 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,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ILPC442U
• Device Lot Number: 2022061579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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
• Treatment: DENTAL IMPLANT
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Male
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic