MAUDE Adverse Event Report: ZIMVIE US CORP LLC TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 5MM(P) 5MM(H); DENTAL ABUTMENT

Catalog Number	TEEHA355
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).H11: d10 - medical product - tsx implant, 4.1mmd, 11.5mml catalog #: tsx41b11 lot #:2120020369.
Event or Problem Description
It was reported that when we put the healing abutment in the dr.Didn't like the position of the implant so we decided to take the abutment out and the implant came with it.So they got stuck together.We had to place another implant due to the healing abutment and implant sticking together.Had to take the implant and abutment out and put a new implant and abutment in.So it added more time on to the appointment.

• Brand Name: TSV® BELLATEK® ENCODE® EMERGENCE HEALING ABUTMENT 3.5MM(D) 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: 24925051
• Report Number: 0001038806-2026-02140
• Device Sequence Number: 10276380
• Product Code: NHA
• UDI-Device Identifier: 00844868045762
• UDI-Public: (01)00844868045762(17)301202(10)4110000301
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K212730
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 06/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: TEEHA355
• Device Lot Number: 4110000301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/20/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: D10, MEDICAL PRODUCT: SEE H11 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic