MAUDE Adverse Event Report: BIOMET 3I CERTAIN¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(H)

Model Number IEHA343

Device Problem Separation Problem (4043)

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

Event Type  malfunction  

Event Description

It was reported that the patient saw general dentist to fabricate implant crown, general dentist was unable to remove healing abutment.Patient was sent to us to have healing abutment removed and place a new one.Tooth site # 4.

Manufacturer Narrative

Zimvie complaint: (b)(4).Patient weight is not provided / unknown.Date of event is not provided / unknown.

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; d9: device availability; 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 product was returned, and the reported event was non-verifiable without return of all devices involved.Based on the evaluation, device malfunction has not 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 product.Therefore, based on the available information, the product was within specifications and conforming when it left zimmer biomet.Dhr review was completed for the subject lot number.It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformance's, which could have caused or contributed to the reported event, were noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review was performed for the reported lot number for similar events and no other complaint was identified.A definitive root cause could not be identified.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.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.

• Brand Name: CERTAIN¿ BELLATEK¿ ENCODE¿ HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 3MM(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: 15503899
• MDR Text Key: 305348665
• Report Number: 0001038806-2022-01484
• Device Sequence Number: 1
• Product Code: NHA
• UDI-Device Identifier: 00844868004516
• UDI-Public: (01)00844868004516(17)241027(10)1233248
• 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: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IEHA343
• Device Catalogue Number: IEHA343
• Device Lot Number: 1233248
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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
• Patient Age: 68 YR
• Patient Sex: Female