MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 6MM(D) 7.5MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	IEEHA675
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: weight unknown / not provided customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that the healing abutment is not engaging into the implant at tooth site #18.Did not seat even with the profiler.Another healing abutment was opened and seated with no problem.

• Brand Name: CERTAIN® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 6MM(D) 7.5MM(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: 25135365
• Report Number: 0001038806-2026-02590
• Device Sequence Number: 9453325
• Product Code: NHA
• UDI-Device Identifier: 00844868045717
• UDI-Public: (01)00844868045717(17)301209(10)4110000265
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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
• 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: Lay User/Patient
• Device Catalogue Number: IEEHA675
• Device Lot Number: 4110000265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN IMPLANT
• Patient Age: 57 YR
• Patient Sex: Female