MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.1MM(D) 6MM(P) 7MM(H); DENTAL ABUTMENT

Catalog Number	IEEHA467
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the healing abutment could not be fully connected to the implant at tooth site #20.A healing abutment of the same part number was connected to complete the procedure.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Product has been received by zimvie and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 4.1MM(D) 6MM(P) 7MM(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: 24924847
• Report Number: 0001038806-2026-02136
• Device Sequence Number: 9153332
• Product Code: NHA
• UDI-Device Identifier: 00844868045533
• UDI-Public: (01)00844868045533(17)290620(10)1282803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2026

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: IEEHA467
• Device Lot Number: 1282803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/20/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN IMPLANT
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic