MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM; DENTAL IMPLANT

Catalog Number	XIFNT410
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight unknown / not provided, e1: reporter name unknown / not provided.
Event or Problem Description
The doctor reports that the dental implant located in position 36 suffered a fracture of the head, making its rehabilitation unfeasible.Only a fragment of the implant was returned.The implant remains in mouth and must be removed in the future, and a new implant installation will be performed, followed by a new crown and trans epithelial abutment.Procedure not completed.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).The following fields have been updated: b4: date of this report b5: describe event or problem 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) portion / fragment of the xifnt410, (osseotite® tapered certain® implant 4 x 10mm) for evaluation.Visual evaluation of the as returned device identified the implant fragment with signs of use.The implant fragment appears fractured at the collar region.Functional testing to recreate the reported event could not be performed due to the nature of the device & event.Dhr review was completed for the subject lot number 2019091863.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2019091863 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture implant¿ the customer did submit three (3) x-ray images for the reported event.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: OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 10MM
• Common Device Name: DENTAL IMPLANT
• 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: 23510696
• Report Number: 0001038806-2025-03040
• Device Sequence Number: 15869774
• Product Code: DZE
• UDI-Device Identifier: 00844868021957
• UDI-Public: (01)00844868021957(17)241008(10)2019091863
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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 Expiration Date: 10/08/2024
• Device Catalogue Number: XIFNT410
• Device Lot Number: 2019091863
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/16/2025
• 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: 11/10/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2019
• 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: 45 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic