MAUDE Adverse Event Report: BIOMET 3I OSSEOTITE¿ TAPERED CERTAIN¿ IMPLANT 5 X 11.5MM; DENTAL IMPLANT

Catalog Number	XIFNT511
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Inflammation (1932); Osteolysis (2377)
Date of Event	09/24/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimvie complaint number (b)(4).A1: patient identifier: unknown / not provided.
Event or Problem Description
The doctor reports that the dental implant located in position number #26 failed because it fractured by the body and was removed.The doctor reports that the procedure was not concluded by placing another implant.Bone loss and inflammation were reported as a result of the event.
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) xifnt511, (osseotite tapered certain implant 5 x 11.5mm) for evaluation.Visual evaluation was performed, a fracture has been identified on the implants body.Device history record (dhr) review was completed for the subject lot number 2020110467.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 2020110467, for similar events and no other complaint was identified.Review completed utilizing keywords: dental: functional: fracture: implant.Based on the investigation and risk management file review, the most likely root cause determined from the investigation was clinician selects implant that is unable to resist long-term occlusal loading.Therefore, based on the available information, a device malfunction did occur.The fracture has been identified on the body.The reported event was confirmed.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.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¿ TAPERED CERTAIN¿ IMPLANT 5 X 11.5MM
• Common Device Name: DENTAL IMPLANT
• Manufacturer (Section D): BIOMET 3I; 4555 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): BIOMET 3I; 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: 22070995
• Report Number: 0001038806-2025-01179
• Device Sequence Number: 18466922
• Product Code: DZE
• UDI-Device Identifier: 00844868022015
• UDI-Public: (01)00844868022015(17)251125(10)2020110467
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K130949
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• 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): 08/18/2025

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: 11/25/2025
• Device Catalogue Number: XIFNT511
• Device Lot Number: 2020110467
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/02/2025
• 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: 05/22/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• 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: 60 YR
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic