MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(H); DENTAL ABUTMENT

Catalog Number	ILPC443U
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Ilpc443u, certain® low profile one-piece abutment 4.1mm(d) x 3mm(h) lot 2022090262.
Event or Problem Description
Doctor reported fracture of multiunit screws tightened at 10 n.Placement date: (b)(6) 2025, removal date: (b)(6) 2026.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 3MM(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: 24869883
• Report Number: 0001038806-2026-02019
• Device Sequence Number: 8921261
• Product Code: NHA
• UDI-Device Identifier: 00844868021056
• UDI-Public: (01)00844868021056(17)270915(10)2022090262
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K092341
• 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
• Initial Reporter Occupation: Dentist
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: ILPC443U
• Device Lot Number: 2022090262
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/23/2026
• 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: 04/14/2026
• Supplement Report FDA Received Date: 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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: DENTAL ABUTMENT SEE H10 NARRATIVE
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic