MAUDE Adverse Event Report: BIOMET 3I CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H)

Catalog Number IEHA354

Device Problem Separation Failure (2547)

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

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).

Event Description

It was reported that 2 weeks after the final check the patient went to the dentist to start the final restoration and they were unable to remove the healing abutment.It was cold welded.They sent the patient back to the oral surgeon and they were also unable to remove the abutment even after drilling away the screw head and the implant eventually backed out.Tooth site #14 (universal).

Event Description

No additional or corrected information to report.

Manufacturer Narrative

This report is being submitted to report additional information.The following sections are being reported: d4: expiration date and unique identifier (udi) number.H2: if follow-up, what type.H3: device evaluated by manufacturer.H4: device manufacturer date.H6: type of investigation.H6: investigation findings.H6: investigation conclusions.H10: additional narratives/data.The reported event is confirmed following functional testing of the returned product.Based on the evaluation, devices malfunction has occurred.Additionally, 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 device.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming products.Therefore, based on the available information, the products were within specifications and conforming when they left zimmer biomet.The dhr was not available electronically for the subject lot number.Therefore, it could not be further reviewed at the time of the investigation.A notification has been sent to manufacturing to request the dhr for review.The pce will be reopened and updated if there is any indication of nonconformance, or any possible manufacturing issue related to the reported event.Complaint history review was completed for the subject lot number and no other complaint was identified.Functional testing was performed for the returned device and could not be disengaged.The event could be recreated.The complaint is related to the functional performance of the device.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.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 3.4MM(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: 12356825
• MDR Text Key: 267819008
• Report Number: 0001038806-2021-01588
• Device Sequence Number: 1
• Product Code: NHA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IEHA354
• Device Lot Number: 1238013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/23/2021
• Supplement Dates Manufacturer Received: 01/12/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2020
• 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: BOPT4310
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female