MAUDE Adverse Event Report: ZimVie US Corp LLC ABUT CONTOUR 4.5X5.5 3 MM CUFF; Dental Abutment

Catalog Number	ZOA453S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the doctor followed the tsv prosthetic procedures to seat the abutment- zoa453s to the implant tsvwb10.After 2 years, the abutment screw broken.Therefore, the doctor replaced the abutment.Abutment placed on (b)(6)2024 and removed on (b)(6)2026.Tooth site 36.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).

• Brand Name: ABUT CONTOUR 4.5X5.5 3 MM CUFF
• 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: 50771253
• Report Number: 0001038806-2026-04792
• Device Sequence Number: 9424965
• Product Code: NHA
• UDI-Device Identifier: 00889024020856
• UDI-Public: (01)00889024020856(17)260325(10)2021030981
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K052600
• 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,Distributor
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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 Expiration Date: 03/25/2026
• Device Catalogue Number: ZOA453S
• Device Lot Number: 2021030981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2021
• 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 Sex: Female