MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)

Model Number IEHA454

Device Problem Mechanical Problem (1384)

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

Event Date 01/21/2022

Event Type  Injury  

Event Description

Customer reported that they were unable to get the abutment to seat into the implant and the implant was removed.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).

Manufacturer Narrative

This report is being submitted to report additional information.The reported product was not returned.The reported event could not be verified for the unreturned product.Based on the evaluation, device malfunction could not be verified for the unreturned product.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 event.Monthly post market trending review identified no actionable trends or corrective actions for the reported event or devices.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 for the lot had revealed no deviations nor non-conformances which could have caused or contributed to the reported events.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.The complaint is related to the functional performance of the devices.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.Zimmer biomet will continue to monitor for trends.

Event Description

No additional or corrected information to report.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• Type of Device: HEALING 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: 13481269
• MDR Text Key: 285245090
• Report Number: 0001038806-2022-00171
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868004646
• UDI-Public: (01)00844868004646(17)240526(10)1228807
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IEHA454
• Device Catalogue Number: IEHA454
• Device Lot Number: 1228807
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BOST410.
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Male