MAUDE Adverse Event Report: ZimVie US Corp LLC Contour Abutment, 2.9mmD Platform, 3.7mmD Emergence Profile, 1.5mm Cuff; Dental Abutment

Catalog Number	CANP31A
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury

• Brand Name: Contour Abutment, 2.9mmD Platform, 3.7mmD Emergence Profile, 1.5mm 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: 50929465
• Report Number: 0001038806-2026-04925
• Device Sequence Number: 18564166
• Product Code: DZE
• UDI-Device Identifier: 00889024343085
• UDI-Public: (01)00889024343085(17)300701(10)2120035417
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K142082
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: CANP31A
• Device Lot Number: 2120035417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female