MAUDE Adverse Event Report: ZIMMER DENTAL ABUT ZIRCONIA3.5 X 4.5 1; DENTAL ABUTMENT

Catalog Number	ZRA341S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
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.A4: patient weight: unknown / not provided.D4: expiration date: unknown / not provided.
Event or Problem Description
The doctor reports that the dental abutment located in position number 12 failed because it fractured at the body.Abutment was placed on 15 oct 2024 and removed on 01 may 2025.The doctor reports that the procedure was concluded by placing another abutment hla3/3.
Additional Manufacturer Narrative
Zimvie complaint number: (b)(4).The following fields have been updated: b4: date of this report.B5: describe event or problem.D4: unique identifier (udi) number.G3: date received by manufacturer.G6: type of report.H1: type of reportable event.H2: follow up type.H3: device evaluated by manufacturer.H6: adverse event problem.H10: additional narrative.Zimvie received one (1) zra341s, (abut zirconia3.5 x 4.5 1) for evaluation.Visual evaluation of the as returned device identified the abutment with signs of use.The abutment was observed fractured at the hex region.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.This complaint refers to the specific device being investigated for this complaint record.The dhr was requested; however, an electronic copy is not available for review.The investigation will be reopened and updated upon any new or additional information provided to this complaint.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product is within specifications.Complaint history review was performed for the reported lot number 2022051078 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture abutment.¿ based on the investigation and risk management file review, the most likely root causes determined from the investigation are parafunctional habits/patient factors, or customer error.Therefore, based on the available information, a device malfunction did occur.The reported event was confirmed with all the available information.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the product was nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.At this time, the complaint investigation has been completed and the record will be closed.If additional information is received, the record will be re-opened for further evaluation.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT ZIRCONIA3.5 X 4.5 1
• Common Device Name: DENTAL ABUTMENT
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer Contact: carlos gordian-arroyo ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 22961453
• Report Number: 0002023141-2025-02420
• Device Sequence Number: 20897918
• Product Code: NHA
• UDI-Device Identifier: 00889024021488
• UDI-Public: (01)00889024021488(10)2022051078
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K061847
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: ZRA341S
• Device Lot Number: 2022051078
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/11/2025
• 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: 09/04/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2022
• 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
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic