MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.1MM(D) 4.1MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	IEEHA445
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).A2: age and date of birth unknown / not provided.A4: patient weight unknown / not provided.
Event or Problem Description
It was reported that ha would not fit into the implant.Opened a brand new 4.1x4.1x5mm encode ha and it would not sit into the implant, there was a gap between the ha and the implant, attempted to re-seat and had to improvement, radiograph were taken documenting the problem.Tooth site # 37.Additional appointment required, will need to use a scan body.The procedure completed using another ha, fit fine.
Additional Manufacturer Narrative
Zimvie did not receive one (1) ieeha445, (certain bellatek encode emergence healing abutment 4.1mm(d) 4.1mm(p) 5mm(h)) for evaluation.Visual inspection could not be performed.The investigation has been performed based on the available information using the item number, device history record (dhr) review, and risk management file (rmf).Dhr review was completed for the subject lot number 1280493.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1280493 for similar events and no other complaint was identified.The customer did not submit images for the reported event.Based on the investigation and risk management file review the most likely root cause determined from the investigation was torque applied during placement/seating exceeds recommended value.Therefore, based on the available information, a device malfunction could not be verified.The reported event is non-verifiable.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report.G3: date received by manufacturer.G6: checked "follow-up".H3: changed "no" to "yes".H6: entered evaluation codes.H11: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
Zimvie received one (1) ieeha445, (certain bellatek encode emergence healing abutment 4.1mm(d) 4.1mm(p) 5mm(h)) for evaluation visual evaluation was performed, abutment was functionally tested with in-house implant and fully engages and disengages as intended.No malfunction identified.Dhr review was completed for the subject lot number 1280493.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 1280493 for similar events and no other complaint was identified.The customer did not submit images for the reported event.A definitive root cause could not be determined since device malfunction did not occur.The reported event was unconfirmed following functional testing and physical evaluation.Therefore, based on the available information, a device malfunction did not occur.The abutment fully seats with in-house implant.The reported event is unconfirmed.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.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.The following sections have been updated: b4: date of this report.D9: device availability.G3: date received by manufacturer.G6: checked "follow-up".H2: checked follow-up type.H3: changed "no" to "yes".H6: entered evaluation codes.H11: added manufacturer narrative.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.1MM(D) 4.1MM(P) 5MM(H)
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMVIE US CORP LLC; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 24444230
• Report Number: 0001038806-2026-00997
• Device Sequence Number: 16043301
• Product Code: NHA
• UDI-Device Identifier: 00844868045465
• UDI-Public: (01)00844868045465(17)290502(10)1280493
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K212730
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/04/2026

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: Other
• Device Catalogue Number: IEEHA445
• Device Lot Number: 1280493
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 04/24/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic