MAUDE Adverse Event Report: ZimVie US Corp LLC ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM; Dental Abutment

Catalog Number	TAC2
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Doctor reported screw fracture.Patient came referring mobility on bridge supported by implant, doctor noticed that multi-unit screw of one of the abutments of the 3 piece-bridge fractured.Procedure was completed with a new multi-unit of height 35.2 mm.Tooth site 14.Abutment placement date: (b)(6) 2018, abutment removal date: (b)(6) 2026.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4) g4: premarket identification pma/510(k) #: k013227.

• Brand Name: ABUT TAPERED ONE-PIECE SCR-V 3.5MM 2MM
• 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: 50816767
• Report Number: 0001038806-2026-04830
• Device Sequence Number: 16122309
• Product Code: DZE
• UDI-Device Identifier: 00889024018419
• UDI-Public: (01)00889024018419(17)310305(10)4120007153
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011028
• 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
• Report Date (Section B): 09/18/2026

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: TAC2
• Device Lot Number: 4120007153
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 176 LB