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

Model Number	IEHA454
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that the product is defective per the oral surgeon.The product did not fit properly.Customer used another device to complete the procedure.No other symptoms were reported.Patient wont return for an additional appointment.Tooth # not reported.
Additional Manufacturer Narrative
An unk implant and two certain bellatek encodehealing abutment 4.1mm(d) x 5mm(p) x 4mm(h) (2x ieha454) were not returned for investigation.Since products have not been returned, visual/functional inspection could not be performed.The investigation has been performed based on the available information.Functional testing to recreate the reported event could not be performed due to the nature of the device and event.Pre-existing patient factors, x-ray, tooth location is not relevant to the reported event.The length of the device usage is unknown.Pictures were not provided.Appropriate documentation was reviewed.Dhr review was completed for the subject lot number (1236825).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Dhr review could not be performed, as the lot number associated with the reported product is not available.Zimmer biomet quality management system (qms) has controls in place to ensure the distribution of conforming product within specifications.No complaint history review could be performed without relevant lot and item information for unk implant.Complaint history review was performed for the reported lot number (1236825) for similar event and no other complaint was identified.Post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction could not be verified, and the reported event was non-verifiable.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "yes" to "no".H6: entered evaluation codes.H10: added manufacturer narrative.H3 other text : device not returned.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 4MM(H)
• Common Device Name: 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: 14321941
• Report Number: 0001038806-2022-00656
• Device Sequence Number: 12061514
• Product Code: NHA
• UDI-Device Identifier: 00844868004646
• UDI-Public: (01)00844868004646(17)250317(10)1236825
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K072642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2025
• Device Model Number: IEHA454
• Device Catalogue Number: IEHA454
• Device Lot Number: 1236825
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 10/22/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose