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 Codes	Fracture (1260); Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A2: age at time of the event: unknown / not provided.A4: patient weight: unknown / not provided.
Event or Problem Description
The doctor reports that the dental implant located in position number 15 failed because it fractured at the head.Non integration with infection was also reported.The doctor reports that the procedure was not concluded by placing another implant.
Additional Manufacturer Narrative
Zimvie complaint number (b)(6).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, minor bone / tissue attached to external threads.The alleged reported implant fracture was not identified.Functional testing to recreate the reported events could not be performed due to the nature of the device & events.Dhr review was completed for the subject lot number 2120007064.No deviations or non-conformances, which could have caused or contributed to the reported events, were noted as part of the dhr.Complaint history review was performed for the reported lot number 2120007064 for similar events and no other complaint was identified.Review completed utilizing keywords: ¿fracture implant¿ & ¿non-integration infection¿ a definitive root cause could not be determined since the device malfunction did not occur, and the reported event (fracture implant) has been unconfirmed following visual and physical evaluation.Refer to attached summary investigation for ¿infection¿ therefore, based on the available information, a device malfunction did not occur.The reported event (fracture implant) was unconfirmed with all the available information.Non-integration infection is a medical condition and is non-verifiable with the information provided.No further investigation or immediate capa / hhe/d escalation is required, as the complaint investigation did not confirm the products were nonconforming at the time of distribution, and no new failure mode, harm, or hazardous situation was identified through the investigation performed.Similar complaints for implant infection have been previously investigated.Refer to attached summary investigation.Visual and dimensional evaluations of the previously returned product have not identified or suggested manufacturing non-conformances.While non-conformances were identified for some lots during manufacturing record reviews, the documented disposition actions for each did not suggest the likely release of non-conforming product.Zimvie quality management system (qms) has controls in place to ensure the distribution of conforming product.Additionally, all device history record reviews verified that each implant was sterilized per procedure for every device.All complaint data used for the summary investigation was found to be conforming and did not meet capa/hhe/d/ or any further escalations.Therefore, there were no complaints which confirmed a manufacturing or design related issue that did or could cause or contribute to the reported event.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® 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: 23485895
• Report Number: 0001038806-2025-02970
• Device Sequence Number: 21415058
• Product Code: DZE
• UDI-Device Identifier: 00844868023135
• UDI-Public: (01)00844868023135(17)290121(10)2120007064
• 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: 2024
• 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 Catalogue Number: XIFOSM385
• Device Lot Number: 2120007064
• 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: 11/06/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: Unknown
• Patient Ethnicity: Non Hispanic