MAUDE Adverse Event Report: BIOMET 3I; DENTAL ABUTMENT

Device Problem Unintended Movement (3026)

Patient Problem Pain (1994)

Event Date 10/20/2022

Event Type  Injury  

Event Description

It was reported that the crown/abutment would not seat.The final abutment did not fully seat and was loose for quite some time.This condition resulted in the stripped internal hex and the implant is no longer restorable.A new implant will be placed in phase ii.Tooth site # 19 (universal).Symptoms: pain, prolonged treatment and repeat procedures.

Manufacturer Narrative

Zimvie complaint (b)(4).Brand name is not provided / unknown.Catalog number and lot number are not provided / unknown.Concomitant medical products: xiitp6513, osseotite, tapered certain, prevail, implant 6/5 x 13mm, lot number 2016110513.Initial reporter¿s title and last name are not provided / unknown.

Manufacturer Narrative

This report is being submitted to report additional information.The following sections are being reported: if follow-up, what type device evaluated by manufacturer type of investigation investigation findings investigation conclusions additional narratives/data based on the available information, device malfunction could not be verified.However, there is no existing nonconformance / capa / hhe/d / ie / product hold against the reported device that did or could cause or contribute to the reported events.Monthly post market trending review identified no adverse trends or actionable trends for the reported event or device.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the product was within specifications and conforming when it left zimvie.Dhr review, and complaint history review could not be performed, as the lot number associated with the reported product is not available.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.A definitive root cause could not be determined.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimvie will continue to monitor for trends.

Event Description

No additional or corrected information to report.

• 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: 15833176
• MDR Text Key: 303996666
• Report Number: 0001038806-2022-01795
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2022
• Initial Date FDA Received: 11/21/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: 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: 60 YR
• Patient Sex: Female
• Patient Weight: 83 KG