MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 02/28/2022

Event Type  Injury  

Event Description

It was reported that the patient could not tolerate healing abutments.The abutments were causing ulcerations and lip swelling.The final restoration would have caused similar problems, therefore the implants were removed.Tooth sites: 22 and 27.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-00390.Zimmer biomet complaint number (b)(4).Concomitant medical products: bopt4311, 3i t3â® tapered implant 4/3 x 11.5mm, lot# 2021050227.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

No additional event information received at the time of this report.

Manufacturer Narrative

Multiple mdr reports were filed for this event.Please see associated report: 0001038806-2022-00390-1.This report is being submitted to relay additional information and device evaluation.Two (2) 3i t3â® tapered implant 4/3 x 11.5mm (bopt4311) were returned for investigation.The unknown healing abutments were not returned.Visual evaluation of the as returned product identified signs of use, but no apparent malfunction.Based on the evaluation, implant malfunction has not occurred, and abutments malfunction could not be verified.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported devices that did or could cause or contribute to the reported event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review and complaint history review by lot number could not be performed, as the lot numbers associated with the reported product (unknown healing abutment) are not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Therefore, the reported event couldn't be recreated.A definitive root cause could not be identified.However, based on the investigation and risk file review, the most likely causes determined from the investigation are implant not placed properly; clinician error, and missing or confusing instructions for use.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.H3 other text : device requested but not received.

• 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 ; 5617766700
• MDR Report Key: 13864139
• MDR Text Key: 287803253
• Report Number: 0001038806-2022-00391
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2022
• Initial Date FDA Received: 03/23/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 75 YR
• Patient Sex: Female
• Patient Weight: 68 KG