MAUDE Adverse Event Report: ZIMMER DENTAL IMPL SWISSPLUS OCTAGON 4. 1MM 12MM; DENTAL IMPLANT

Catalog Number	OPB12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994)
Date of Event	09/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Multiple reports are being submitted for this event.A1: patient identifier unknown / not provided.G4: pma/510(k) number: k002188.A summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
It was reported that the dental implant located in tooth site #24 failed due to infection.Antibiotic was prescribed and the doctor will wait for regeneration.The doctor reported pain.
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).Dhr review was completed for the subject lot number 63838188.No deviations or non-conformances, which could have caused or contributed to the reported event, were noted as part of the dhr.Sterilization record was reviewed and verified to have passed all sterilization activities with no issues or nonconformities identified.Complaint history review was performed for the reported lot number 63838188 for similar events and two (2) other complaints were identified.Review completed utilizing keywords: ¿infection¿ a summary investigation has been completed for infection events identifying that a definitive root cause cannot be identified due to the wide range of external (non-design/ non-manufacturing related) factors potentially impacting the sterility of the implant and its environment.Should additional information be received which indicates that the device may have caused or contributed to the infection event, an additional report will be submitted.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: IMPL SWISSPLUS OCTAGON 4. 1MM 12MM
• Common Device Name: DENTAL IMPLANT
• 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: mark mashburn ; 4555 riverside drive; palm beach gardens, FL 33410 ; 5619713230
• MDR Report Key: 23358145
• Report Number: 0001038806-2025-02614
• Device Sequence Number: 8965500
• Product Code: DZE
• UDI-Device Identifier: 00889024015807
• UDI-Public: (01)00889024015807(17)221130(10)63838188
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K011245
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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?: No
• Operator of Device: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: OPB12
• Device Lot Number: 63838188
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 10/01/2025
• 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: 10/22/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2017
• 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 Age: 58 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic