MAUDE Adverse Event Report: ZIMVIE US CORP LLC OSSEOTITE® CERTAIN® 2 IMPLANT 3.25 X 8.5MM; DENTAL IMPLANT

Catalog Number	XIFOSM385
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reports a fracture of the dental implants located in positions 36 and 35, as well as of the occlusal screw.Procedure completed.This report refers to second implant fractured.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A4: patient weight: unknown / not provided d10: concomitant medical product: xifosm385, osseotite® certain® 2 implant 3.25 x 8.5mm, lot: 2021080264 unknown zimvie screw, lot: unknown.
Event or Problem Description
No further event information is available at the time of this report.
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) xifosm385, (osseotite® certain® 2 implant 3.25 x 8.5mm) for evaluation.Visual evaluation of the as returned device identified the implant with signs of use, apparent bone / tissue was seen attached to the internal threads, and some damage around the external threads likely caused during removal.Implant fracture identified at the collar.Additionally, an unknown fractured screw fragment was identified stuck inside the implant.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 2021080264.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 2021080264 for similar events and one (1) other complaint was identified.Review completed utilizing keywords: ¿fracture implant¿ 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.

• Brand Name: OSSEOTITE® CERTAIN® 2 IMPLANT 3.25 X 8.5MM
• 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: 23508180
• Report Number: 0001038806-2025-03022
• Device Sequence Number: 9048675
• Product Code: DZE
• UDI-Device Identifier: 00844868023135
• UDI-Public: (01)00844868023135(17)260909(10)2021080264
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100724
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 12/16/2025

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: Other
• Device Expiration Date: 09/09/2026
• Device Catalogue Number: XIFOSM385
• Device Lot Number: 2021080264
• 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: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DENTAL IMPLANT AND SCREW, SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic