MAUDE Adverse Event Report: ZimVie US Corp LLC CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM; Dental abutment

Catalog Number	IEDAT5
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the screw loosened and bite seems off.Tooth site 30.No harm to patient.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event unknown / not provided.A4: patient weight unknown / not provided.D4: expiration date unknown / not provided.D9: device availability unknown / not provided.

• Brand Name: CERTAIN® BELLATEK® TITANIUM ABUTMENT 5.0MM
• 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 ; +1(561)971-3230
• MDR Report Key: 50895009
• Report Number: 0001038806-2026-04874
• Device Sequence Number: 16123283
• Product Code: NHA
• UDI-Device Identifier: 00844868031192
• UDI-Public: (01)00844868031192(17)991231(10)1110026317
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K052648
• 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: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: IEDAT5
• Device Lot Number: 1110026317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2026
• 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
• Patient Sex: Male