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 Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the abutment broke in the implant for no clear reason.The abutment was able to be removed and needs to place another one.

Manufacturer Narrative

This report is being submitted to report additional information.The following sections are being reported: d9: device availability h2: if follow-up, what type h3: device evaluated by manufacturer h6: type of investigation h6: investigation findings h6: investigation conclusions h10: additional narratives/data zimvie received one one-piece abutment for evaluation.Visual evaluation was performed, the abutment screw was fractured.The fractured piece wasn¿t returned.Dhr review and complaint history review by lot number could not be performed, as the lot number associated with the reported product is not available.However, zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.A complaint history review by item number was conducted dating back to 12 months from now.The complaint history review revealed that there are no existing non-conformances/capa/hhe/d/product holds for the reported product for similar event.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was missing or confusing instructions for use or clinician incorrectly engages abutment screw into implant.Therefore, based on the available information, a device malfunction did occur.The abutment screw was fractured.The reported event was confirmed.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.

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: susanne taylor ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 18397169
• MDR Text Key: 331365143
• Report Number: 0001038806-2023-02494
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,User Facility
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: ILPC442U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic