MAUDE Adverse Event Report: ZIMVIE US CORP LLC CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(H); DENTAL ABUTMENT

Catalog Number	ILPC341U
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).A1: patient identifier unknown / not provided.A2: age at time of the event unknown / not provided.A3: gender unknown / not provided.A4: patient weight unknown / not provided.B3: date of event unknown / not provided.D10.Concomitant medical products.Ilpc343u, certain® low profile one-piece abutment 3.4 mm(d) x 3 mm(h) lot 2120030222.
Event or Problem Description
It was reported that the multi unit abutment screws fractured.The clinician was trying to screw the scanbody for taking impressions and the abutments came together.The fractured part of the screw was removed.Tooth location 23 and 13.

• Brand Name: CERTAIN® LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 1MM(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: 25123397
• Report Number: 0001038806-2026-02561
• Device Sequence Number: 13446240
• Product Code: NHA
• UDI-Device Identifier: 00844868021117
• UDI-Public: (01)00844868021117(17)300609(10)2120033821
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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,Followup
• Report Date (Section B): 07/06/2026

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: ILPC341U
• Device Lot Number: 2120033821
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/21/2026
• 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; Not provided
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 05/13/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2025
• 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: DENTAL ABUTMENT SEE H10 NARRATIVE.
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic