MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 5MM(D) 6MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	IEEHA565
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided.E1: last name unknown / not provided.
Event or Problem Description
It was reported that patient came in to get (stage 2) uncover and implant looked great, when doctor went to put abutment on, it wouldn't "seat" or screw in to implant as it should have.Doctor went and got a new one in the box (same size) and it went perfectly, not sure why this one wouldn't work.Tooth number: 19.
Additional Manufacturer Narrative
Zimvie received one (1) ieeha565, (certain® bellatek® encode® emergence healing abutment 5mm(d) 6mm(p) 5mm(h)) for evaluation.Visual evaluation of the as returned device identified the encode abutment with signs of use and was identified as reported.During a functional test the returned encode abutment seated as intended with an in-house biomet implant.No apparent malfunction was identified.This complaint refers to the specific device being investigated for this complaint record.Dhr review was completed for the subject lot number 1296891.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 1296891 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 is incorrect technique used - customer error.Therefore, based on the available information and functional testing, the abutment malfunction did not occur.The reported event was non-verifiable with all the available information.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.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", 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 5MM(D) 6MM(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: 24747873
• Report Number: 0001038806-2026-01735
• Device Sequence Number: 8772224
• Product Code: NHA
• UDI-Device Identifier: 00844868045618
• UDI-Public: (01)00844868045618(17)300319(10)1296891
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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
• Report Date (Section B): 05/11/2026

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: IEEHA565
• Device Lot Number: 1296891
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2025
• 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 Age: 70 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic